PPD

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health . You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our clinical department defines, develops and delivers clinical programmes. We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study, ensuring that patients receive needed care, as well as identifying and treating clinical trial participants. We are currently looking for an Associate Director who will join our global Site Payments department and will be based in EMEA. This role will ensure delivery of complete set-up, processing, reconciliation and reporting for all site payments generated from subject activities. Summarized Purpose : Directs the delivery of investigator payments through oversight of managers and coordinators. Ensures delivery of complete set-up, processing, reconciliation and reporting for all site payments generated from subject activities. Accountable for delivery to contracted milestones and budgets and the adherence to departmental and study specific processes. Resolves moderate to complex internal and external payment escalations and works effectively across PPD functions to issue on time and accurate payments. May be fully assigned to specific priorities such as FSP, site networks, or strategic partners depending upon department priorities. Essential Functions: Provides effective risk management for assigned book of business in order to realize study or portfolio objectives. Ensures managers and coordinators are aware of and adhere to study level KPIs, KQIs, timelines, and other contracted deliverables. Ensures individual project targets achieve contracted requirements, and/or departmental level KPIs, KQIs. Ensures individual projects are adequately resourced, including holiday coverage, to seamlessly achieve contracted deliverables and immediately escalates any risks to deliverables. Ensures services are delivered according to departmental and corporate SOPs. Manages across global locations to address questions, resolve escalations, and ensure delivery of payments. Effectively uses study level reports to proactively assess team performance and to issue immediate measures as needed. Develops reports for internal and external customers, which may include payment status, reconciliations, transparency regulations, FSP, strategic partners, site networks, accruals, and others. Develops and maintains policies, procedures, and training for use by department and other departments, and delivers training as needed. Attends CRRMs and promptly manages escalated actions to resolution. Leads CAPA or audit investigations, completes responses, and provides updates and training to department staff on any corrective actions to ensure long term compliance. Ensures managers and coordinators reach utilization targets. Leads managers and teams by establishing a challenging, motivating and collaborative work environment for an effective and productive team. Develops and maintains our performance culture by creating succession plans for key managers/roles, providing training, establishing development plans, and distinguishing high performers during annual performance reviews. Conducts performance evaluations, makes decisions in hiring, promotions, salaries, and takes actions for underperforming personnel. Partners with other departments to ensure services are provided according to contracted timelines and to address issues, create reports, manage sponsor requests, etc. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years). Experience in clinical drug development and clinical trials process within the pharmaceutical and/or CRO industry is preferred.5+ years of management responsibility Proven leadership skills Knowledge, Skills and Abilities: Comprehensive understanding of end to end clinical trial payment processes, including financial process of accounts payable and escrow accruals Capable of analyzing data to anticipate and mitigate risk Capable of working under pressure with limited information Strong interpersonal, negotiation, and problem-solving skills to influence and persuade to effectively promote ideas Effective collaborative relationship building skills to ensure operational execution Demonstrated strong leadership style, with concise, well organized oral and written communication skills Capable of motivating direct reports and subordinates to reach team objectives In-depth understanding of managing project budgets and metrics Effective oral and written communication skills Excellent organizational skills and strong attention to detail Strong computer skills, particularly MS Word, Excel, Power Point Capable of working independently Capable of supervising, evaluating, leading, engaging, motivating, and mentoring departmental personnel Capable of delegating tasks and facilitating the completion of assignments What we offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme , ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD clinical research services truly value a work-life balance. We ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world s most urgent health needs, submit your application - we d love to hear from you!

Executive Director, Post and Peri Approval This role can be remote or office based from anywhere within EMEA Role Summary: This role will focus on commercial collaboration and growth of key growth targets for the NIS/PPAS team. Accountable for establishing and ensuring successful completion of assigned therapeutic area studies/portfolio/clients through the oversight of relevant resources/functions. Role Responsibilities: Accountable for achieving overall financial goals (sales/repeat business, revenue and profitability). Works globally with other groups to develop new and/or support existing business. Collaborates with leadership in all functional areas on the continuous development/improvement of business processes to support cross functional teams and to ensure that work is uniform, complete and managed appropriately. Develops and drives the specific and overall therapeutic area strategies to ensure optimum performance and achievement of annual plans and targets. Has overall responsibility for instigating and leading change initiatives within the therapeutic area and works with peers of therapeutic areas in the overall leadership of the Project Management group. Ensures the timely execution of clinical trials with a focus on quality deliverables and profitability. Responsible for and ensures proactive identification of project risks and potential contingencies impacting time/quality/cost of deliverables are effectively managed and escalated through appropriate escalation pathways. Further assesses all risks for potential impact across multiple projects and any cross therapeutic impact. Reviews and assesses project profitability by holding project team lead accountable for obtaining appropriate sponsor approval for out of scope work before completing the work. Responsible for escalation and proactive approval of appropriate contingencies having financial impacts. Develops and implements the therapeutic area business plans, forecasting and sales/marketing plans. Fosters and strengthens client relationships and develops the strategic sell initiative of the division. Strategically evaluates PPD against competitors and makes recommendations to increase PPD s competitive position. Provides administrative oversight of the department, including staffing, budgeting, scheduling and long term planning. Provides strategic direction to staff through line management of a team. Accountable for effective recruitment, induction, talent development and retention of staff. Provides ongoing coaching and feedback including formal performance appraisals, development plans and career coaching. Proactively supports and drives business development activities and seeks to obtain additional contracts which may include making presentations to potential clients and representing PPD at appropriate professional meetings and conferences. Serves as designated Customers "Executive" contact person for all issues. Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date and identifies areas of opportunity for improvement. Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems. Qualifications: Education and Experience: Bachelor s, masters or higher licensed certified health care training. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years) or equivalent and relevant combination of education, training, & experience. 8+ years of leadership responsibility. Valid Passport, where appropriate. Knowledge, Skills and Abilities: Ability to develops, drive and execute strategic plans through leveraging relationships and influencing others Demonstrated track record of success in clinical development and in leading and developing professional staff in a project led environment Strategic thinker with proven ability to implement new solutions Proven ability to simultaneously and effectively oversee multiple projects and people Stakeholder and client management skills; solid negotiator, ability to navigate politicized situations, uses influence and credibility, cultivates collaborative internal/external networks/relationships Expertise in budgeting, forecasting and fiscal management Effective oral and written communication skills, including the ability to communicate in English, bothorally and in writing Demonstrates robust judgment, problem solving and decision making. Ability to apply critical and analytical thinking, use data, business acumen and insight to develop effective solutions. Ability to manage complex and ambiguous issues Demonstrates executive presence, acts with integrity, shows personal impact and credibility Demonstrated leadership and emotional intelligence with the ability to read and manage interpersonal dynamics and apply conflict resolution skills Ability to actively develop and harness talent and capabilities within the department, skilled coach and mentor Self-aware and open to learning, ability to act as an ambassador for and foster innovation and change, and skilled in process and continual improvement Effective marketing and organizational skills. Influential communicator, tailors approach to influenceand motivate others Expert knowledge of project management principles and application, Knowledge of regulatory guidelines and directives, medical therapeutic area and medical terminology Solid computer skills Working environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.) As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD, a Division of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion.You will be joining a trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients. Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments. As a Director of QA, you will Lead the Vendor Quality Management team by working across functional groups to advise, coordinate, and provide regulatory and quality support through the full vendor lifecycle for sub-contracted vendors, who provide GxP-regulated products and/or services to PPD and PPD clients. Summarized Purpose: Provides strategic direction, leadership and management of a QA department and/or program. Where and when role requires incumbent provides oversight to auditing techniques, interpretation of regulations and guidelines, clinical supplies, computer validation and compliance, and/or therapeutic training. Assists business development and senior management in securing new business. Develops effective solutions, using proven problem-solving techniques, to address nonconformance issues with existing clients. Responsible for achieving overall financial goals for department. Essential Functions: Prepares the annual vendor audit plan and managing vendor audit escalations Establishes, tracks, and analyzes vendor quality metrics with select strategic vendors Ensures the centralization and maintenance of vendor quality data utilizing the Vendor Management System Works cross-functionally on company-wide vendor management process improvements Develops, updates, and/or assists with vendor management related procedural documents Participates in regulatory inspections and client audits and responds to observations, manages audit review responses, facilitates improvements as needed Participates in business development RFx responses ensuring consistency with vendor management process Oversees establishment of Quality to Quality programs with external suppliers to align and drive efficient collaboration Directs assigned department in execution of departmental objectives. Hires, develops, and mentors staff to expand organizations capability and ensures effective management of staff Manages contracts to ensure contractual obligations and business requirements are met Advises peers, teams, and clients on the interpretation and implementation of regulatory agency trends and requirements Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences Fosters client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues Develops and maintains applicable quality and site metrics. Participates on site quality and business process improvement issues Handles delegated tasks and responsibility as requested by senior leadership Represents QA at client audits and regulatory authority inspections. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Qualifications: Education and Experience : Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years) or equivalent and relevant combination of education, training, & experience. 5+ years of management responsibility Proven leadership skills Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: Excellent leadership skills and business acumen Advanced knowledge of financial management and budgeting Ability to successfully operate in a matrix or team environment Ability to handle multiple responsibilities, priorities and tasks Excellent verbal and written communication skills including appropriate use of medical and scientific terminology Demonstrated proficiency with regulations and guideline interpretation, audit procedures, proper documentation and QA departmental policies and procedures Ability to apply proven problem solving skills Ability to apply business and process improvement methodologies Ability to manage complex projects on time and within budget Management Role : Directs through lower management levels and / or highly skilled specialist employees who exercise significant latitude and independent judgment. Often heads one or more departments or a large, centralized staff function. In some instances, may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions. Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, we d love to hear from you!

Centralized Monitoring Analyst I - Data Analytics This role can be based anywhere within EMEA, remote or office based We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Data Analytics is an integral part of PPD s risk-based monitoring strategy, driving centralized monitoring efforts through a new approach to risk surveillance and centralized statistical monitoring. This approach combines the power of statistical and analytical tools with expertise from operationally experienced staff to analyze and monitor clinical trial data. Data Analytics staff (CMAs) holistically explore study data to pinpoint meaningful signals, resulting in more efficient and effective resolution of issues and a proactive approach to risk detection. Using this data driven approach, study teams are able to quickly address systemic problems or site performance, directing remediation activities where needed, and positioning on-site monitoring activity in a targeted approach. As a Clinical Monitoring Analyst within Data Analytics, you ll be supporting centralized statistical and risk surveillance activities on assigned trials. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Summarized Purpose: Identifies and characterizes issues and trends in operational and patient clinical trial data using analytical or statistical tools. Leverages operational experience and knowledge to evaluate issues and develop findings based on data analyzed to communicate issues and potential risks to project team members for follow-up action. Essential Functions: Reviews clinical trial data using a variety of tools and systems in alignment with the centralized monitoring plan with support from senior team members. Characterizes and tracks the evidence of issues, signals and potential risks with support from senior team members. Ensures results of reviews are appropriately documented per department procedures. May participate in development of risk characterization and reporting. Supports review set-up, including updating department database, pulling reports, etc. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years ). Prior experience in clinical monitoring in data analytics, data management, biostatistics or related data field in support of clinical trials is preferred. In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role Knowledge, Skills and Abilities: Capable of applying fundamental knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, global SOPs and client expectations Strong attention to detail and skill with numbers Good analytical /problem-solving skills /judgment in decision making Ability to work productively with direct supervision Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data Flexibility and adaptability Ability to work in a team environment and independently Good oral and written communication skills (English) with the ability to communicate with a variety of internal customers, including project team Good computer skills, with knowledge of MS Office (Word, Excel, PowerPoint) and the ability to learn and use interactive computer systems Ability to extract pertinent information from standard study documentation, such as protocols, electronic study data systems with the ability to learn to identify trending of site/study data Prioritization skills with ability to plan, monitor and manage workload fluidly in response to changing project demands Satisfactory understanding of project protocol, project documentation including Centralized Monitoring Plan and other functional plans Broad working knowledge of the roles, functions and process of conducting clinical trials Broad understanding of medical/therapeutic area knowledge and of medical terminology PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. I-KC2

Regulatory Affairs Director - Customer Dedicated - Oncology We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you re a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD clinical research services is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. We are currently seeking a Regulatory Affairs Director. This is an oversight role within our Regulatory FSP Solutions team. This position is supporting projects for one of our strategic partners on behalf of PPD Clinical Trial Services. This is a full-time, permanent position, and we can offer remote opportunities as well. The purpose of this role is to ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal Client process / policy and with regional regulatory requirements to deliver the best possible labelling, commensurate with the available data. In performing the role, the job holder will be responsible for: • Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally • Implementation of the regional strategy(s) in support of the project globally • Lead regulatory interactions and the review processes in local region • Ensuring appropriate interaction with regional commercial teams in local region • Ensuring compliance with regional requirements at all stages of product life • Ideally able to advocate persuasively approaches to senior leaders in the Business and in Health Authorities • Capable of providing assessment of potential in license molecules Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years). Extensive experience of all phases of the drug development process in regulatory affairs Proven experience of leading regional development, submission and approval activities regionally/globally. Extensive knowledge of clinical trial and licensing requirements in all major countries in the region and ideally sound knowledge globally. Knowledge of Oncology Knowledge, Skills and Abilities: - Mastery of English language (written and oral) communication skills as well as local language where applicable - Sharp attention to detail and quality as well as advanced editorial/proofreading skills - Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments - Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies - Excellent organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects - Professional negotiation skills - Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables - Advanced understanding of medical terminology, statistical concepts, and guidelines - Sharp analytical, investigative and problem-solving skills - Advanced understanding of budgeting and forecasting - Recognized executive presence and consultation and presentation skills - Effective critical and strategic thinking skills At PPD clinical research services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world s most urgent health needs, submit your application - we d love to hear from you! LI-SH1

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations. As a Site Contract Specialist, you will prepare and negotiate contracts, as well as, finalize the contract process At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. Summarized Purpose: Prepares and negotiates contracts, as well as, finalizes the contract process. Liaises and establishes effective relationships with sites and internal functional teams. Ensures quality, objectivity and risk analysis in the efficient delivery of contracts. Essential Functions: * Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process * Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes * Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations * Ensures compliance of budgetary guidance, templates and process * Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes * Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels * Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed up timelines; ensure alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation * Achieve target cycle times for site activations * Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. *Qualifications:* Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years') or equivalent combination of education, training, & experience. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: * Understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws * Demonstrated ability to apply basic principles of investigator grant negotiation * General understanding of business and financial principles that related to service agreements * Effective communication skills (verbal and written) in English and in language spoken at local place of work * Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters * Strong attention to detail * Excellent analytical and decision based thinking * Understanding of the pharmaceutical product development process and involvement of CROs * Able to work independently or in a team environment * Good organizational and time management skills * Working knowledge of PPD SOP and WPDs * Able to organize competing priorities logically and review outstanding contractual risk and issues * Able to effectively use automated systems and computerized applications, such as, Microsoft Outlook, Excel, Word, etc. * Ability to demonstrate a customer focused style of communication, problem solving and collaboration Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner Able to work upright and stationary and/or standing for typical working hours Able to lift and move objects up to 25 pounds Able to work in non-traditional work environments Able to use and learn standard office equipment and technology with proficiency May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments Able to perform successfully under pressure while prioritizing PPD Defining Principles: - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you

* Team Leader, Biostatistics - Remote, EMEA - ₠/£10,000 Joining bonus * We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. We are currently recruiting for an experienced Team Leader or Manager to join our Biostatistics and Programming department in EMEA, working fully remotely in the UK or mainland Europe. As a Team Leader, Biostatistics you will manage a team of Statisticians and Programmers within the department who are responsible for the statistical aspects of clinical trials from design through analysis and reporting, including client or regulatory interactions. Responsibilities include: * Managing staff, which includes interviewing and selection, professional development, goal setting, performance management, behavioural and technical coaching and mentoring. * Ensure effective resource and utilization management of staff. * Support and coach staff to prepare and review statistical reports, clinical study reports, integrated summaries of safety, integrated summaries of efficacy and other documents as required. * Contribute statistical methods section for integrated clinical statistical reports. * Review integrated clinical statistical reports. * Coach staff to effectively communicate with sponsors concerning project work scope and budgetary changes after reviewing with management. * Aid departmental management in process-improvement strategies. Suggest, assess, and provide leadership in the department for such initiatives. * Assure department adherence to good scientific, ethical, and regulatory standards. * May act as lead statistician, project lead, or senior reviewer on multiple projcts, manages project team resources, budget, finance, timelines and ensures SOP compliance with appropriate documentation. *Qualifications:* To be considered for the role, you should have the following qualifications, skills and experience: * Master's degree in statistics, biostatistics, mathematics or related field * Extensive experience of statistics in a clinical trial environment (min 6 years) * Previous line management experience - ideally 2+ years * Ability to mentor, coach and develop staff * Previous experience interviewing internal and external candidates * Excellent understanding of the statistical principles underlying clinical trials * Excellent statistical skills * Excellent understanding of the regulatory issues associated with the reporting of clinical data in the submission process * Great consultative skills * Outstanding SAS® programming skills and familiarity of other statistical packages * Excellent organizational, time management, and planning skills * Capable of adapting and adjusting to changing priorities * Excellent written and verbal communication skills, including proficiency in the English language * Capable of working in a multi-disciplinary team setting * Demonstrated initiative, motivation and problem solving skills * Good mentoring skills as shown by leadership of multiple projects and team members. At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-EM2

* Associate Director, Programming - EMEA, Remote - ₠/£10,000 Joining Bonus * We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our Biostatistics & Programming department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. The AD, Programming role is a senior management position overseeing programming managers and programming staff within the department. The role will interact extensively with a global multi-disciplinary senior management team to identify critical needs and develop strategic initiatives. Responsibilities include: * Managing a global team of senior staff and/or managers within the department. * Department responsibilities include overseeing deliverables, quality and regulatory compliance for PPD developed CDISC SDTM and CDISC eCRT (Define.xml) programming deliverables. * Maintaining current and future CDISC guideline awareness and formulates strategies to lead and drive the technologies and processes forward to ensure overall project success. * Providing client and department-wide consultation on CDISC proposals, integrations and submissions. * Aids in business development activities. * Acts in the project oversight role on multiple projects. *Qualifications:* To be considered for the role, you should have the following qualifications, skills and experience: * MS/MA degree in computer science, statistics, biostatistics, mathematics or related field * At least 7 years of clinical trial experience as a statistical programmer and at least 5 years of leadership experience. Knowledge, Skills and Abilities: * Excellent SAS programming skills and understanding of database structures * Excellent management skills, including developing staff and their career objectives and the ability to motivate and inspire staff * Capable of facilitating communication with clients, project teams, departments and staff * Solid decision-making skills to decide company policies and procedures regarding programming * In-depth understanding of tracking project budgets * Understand and participate in bidding programming work * Demonstrated leadership, motivation and problem-solving capability * In-depth understanding of clinical trials * Effective attention to detail * Capable of effectively organizing and managing multiple staff and assignments * Effective written and verbal communications skills, including proficiency in the English language * Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others and adjust to changing priorities * Proficiency in at least one programming language and strong technical programming skills. At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you #LI-AD1

* Vendor Management Coordinator * We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our Global Clinical Supplies team cover all aspects from purchasing to global inventory management and from distribution to destruction. We have a new vacancy on our Global Clinical Supplies Team for the Vendor Management group for Vendor Management Coordinator. This is a permanent full-time position and can be based in EMEA * Key responsibilities: * * Actively participate in the Global project calls and lead discussions on assigned supply chains * Liaise with global supply vendors * Manage supply through purchase order issue. * Oversee inventory management of products and stock level review. * Have the ability to establish and maintain strong working relationships with suppliers. * Monitor supply and identify and resolve any issues that may arise. * Build/maintain rolling 12 month supply chain forecast to supply study needs. Ability to interpret data and examine trends to plan, organise, schedule and execute current and forecasted materials required to meet supply needs, would be considered an advantage *Qualifications:* * Education and Experience: * * High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years) or equivalent combination of education, training, and experience. * Logistics experience required * Clinical Trial experience preferred Knowledge, Skills and Abilities: * Strong knowledge of the complete clinical supplies life cycle (i.e., manufacturing, packaging, labeling, import and export, storage and handling, distribution and delivery, return and reconciliation, final destruction). * Clinical Supplies knowledge preferred * Focus on Customer Service aligned with highest standards of quality and excellence. * Excellent interpersonal skills and problem solving/decision making skills. * Strong organizational skills required. * Very strong communication skills both written and verbal. * Fluent in English (verbal and written). * Strong IT skills: working knowledge of Microsoft Project, Excel, and Word. At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application (in English) - we'd love to hear from you. *LI-EP1

The HR Advisor drives employee experience and people management philosophies for assigned bu si n e s s g r o up s and is part of the HR Advisory team that ensures * p ** e o pl e m a na g e r s a n d e m p l o y e es are empowered * to foster and maintain a p o sit i v e working relationship a n d en v i r o nm ent. This r o le will h elp cre a te a n d m ai n tain t h e P P D e m p l o y e e e x p erien c e th o r o ug h ef f e c t ive gu i d a n ce a n d c o ac h i n g o f p e o p l e m a n a g e r s a n d e m p l o y e es to ens u re p r o p er res o l u t i o n o n e m p l o y ee r elat i o n s m at t e r s a n d proa c ti v e d e v e l o pm e n t . Job level will be determine based on qualifications of the candidate hired. The levels are HR Specialist or Sr. HR Specialist. Reference the qualifications section of the job posting for more details. Candidates can be home-based or office based and should be located in the UK. * Create, develop, and manage assigned HR Program areas * Build & maintain knowledge of practices for consulting with people management, clients, and employees. * Analyze information regarding best practices for consulting to proactively resolve issues and/or offer solutions to enhance employee experience while driving business initiatives * Support the HR Advisory Leadership on developing and evolving the framework * Utilize data and insights to help build manager competencies that maintain positive employee-employer relationships and foster employee engagement and retention. * Utlizie case management system to track caseload for assigned business groups and direct report's business groups * P r o v i d e e x e m p la r y su pp o r t t o p e o p l e m a n a g ers a n d e m p l o y e es o n PP D e m p l o y e e relat i o n s p r o c e sses, pro g ra m s, a n d p o licie s ; m a n a g e H R c a ses * M a n a g e e m p l o y ee t e r m i n a ti o n s p art n eri n g with the p e o p le m a n a g e r , IT, Faci l iti e s, P a y r o l l , L ega l ; p r epa r e a n d c o lle c t p a p e r w o r k a n d c o o r d i n ate r e p a y m ent and r eco u p proce s s e s ; c o ndu ct e xit i n t e r v i e ws * G u i d e p e o p l e m a n a g ers a n d em p l o y e e s thro ug h le a v e s o f ab s ences * C o mm un ic a te with e m p l o y e e s a n d p e o p le m a n a g ers t o r e spon d , in t erp r e t , and mo n i t o r c o m p lia n ce w ith P P D * p o licies a n d p r o c ed u res, a n d m a k e r e c om m en d at i o n s o n e m p l o y m ent m a t t ers * P r om o te e m p l o y e e e xperi e n ce, en g a g e m e n t a n d r e c ogn iti o n in i tiat i v es to m a n a g ers a n d t h eir t e a m s and c o ach o n en g a g e m ent be s t p ract i ces * P art n er w ith H R c o lleag u e s , CO E s, HR Bus in e s s P art n e rs t h r o ug h t ar g e t ed in i tiat i v es to ad d ress i s sues and * o pp o rtu n it i es f o r i m p r o v e m ent * P r o v i d e gu i d a n ce t o m a n a g ers t o ide n ti f y ap p r o p ri a te c o u rses o f ac t i o n t o r es o l v e p er f o r m a n ce a n d beh a v i o ral iss u es w i th i n e stab l is h ed g u i d eli n es a n d c o n sistent l y acr o ss t h e o r g a n i z ati on * Ens u res that HR legal r e qu i re m ents a r e m et and pr o v i d e risk m iti g at i o n o p t i o n s * C o ndu ct, p la n , o r g a n i z e, a n d lead i n v e sti g at i o n s, incl u d i n g c o ndu cting inte r v i e w s , site v isi t s as n e e d ed, crea t i n g i n v es t i g at i o n pl an s and fi n d i n g o f facts * Act as a neutral pa r t y , and a d vo c a te f o r a b al an ced p e rs p ec t i v e a n d o u t c o m e * Develop a thorough understanding of HR shared services best practices to connect, enhance and optimize HR Advisory work within the model * Participate in highly complex, high risk or highly sensitive ER cases, partnering with HRBPs and business leaders. * Serve as an employee relations and compliance subject matter expert, providing guidance on escalations from assigned team members, legal department, and HRBPs * Track and analyze ER trends, build ER dashboard models, diagnose root causes and develop recommendations for corrective strategies and other proactive initiatives. * Collaborate and partner with HRBPs, COEs, and business leaders to provide appropriate HR Advisory support for business initiatives, mitigate risk, and ensure corporate strategic initiatives are integrated into the pracitices of the HR Advisory team. * Mentor HR Advisors - for Senior Specialist and HR Manager levels *Qualifications:* Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years') or equivalent combination of education, training, and experience.Knowledge, Skills and Abilities: Proficiency in Microsoft Office programs. Demonstrated project leadership and consultancy skills with ability to function as an effective and respected partner to internal clients. Advanced knowledge of employment laws, principles and best practices. Ability to apply advanced knowledge, skills, and expertise to analysis. Good business acumen with ability to understand complex organizational structures and environments. Ability to work with ambiguity and complexity. Demonstrates executive presence and good presentation skills. Ability to influence at all levels of the organization. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.

PPD's mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations. We are currently looking for an experienced Country Approval Specialist to join our team in the UK. As a Country Approval Specialist, you will be responsible for: * Preparing, reviewing and coordinating local regulatory submissions (MoH, EC, additional special national local applications if applicable) * Providing local regulatory strategy advice (MoH &/or EC) to internal clients * Developing and implementing local submission strategy * Providing technical expertise and coordination oversight for projects * Acting as the primary contact for investigators and with the local regulatory authorities to ensure submissions are managed in a timely manner * Acting as a key-contact at country level for all submission-related activities * Achieving PPD's target cycle times for site activations * Preparing the regulatory compliance review packages * Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy * Developing country specific Patient Information Sheet/Informed Consent form documents * Supporting the coordination of feasibility activities, as required, in accordance with agreed timelines. * Ensuring that trial status information relating to SIA activities are accurately maintained * Overseeing country study files and ensures that that they meet PPD WPD's or client SOP's *Qualifications:* To be considered for the role of Country Approval Specialist you should have: * Bachelor's degree in Life Science related discipline * Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations * Effective oral and written communication skills, including fluency in English * Strong attention to detail and quality of documentation * Excellent negotiation and interpersonal skills At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. * #LI-_LS1 *

*£10,000 joining bonus!! Limited time only!* PPD is recruiting for experienced CRA II and Senior CRAs for our growing UK team. As one of the world's largest CRO's; our CRA's have the opportunity to work on challenging projects across a wide range of therapy areas with some of the most innovative pharmaceutical and biotech companies in the world. Our clinical department defines , develops and delivers clinical program mes . We ensure the highest-quality review of data and effective interaction with study sites, including on-site monitoring throughout a study , ensuring that patients receive needed care, as well as identifying and treating clinical trial participants. PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading company amongst CROs and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company. * You should thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, challenging projects. * You will have excellent communication and interpersonal skills and are looking to work in a collegiate environment where you want to take true ownership for your work. * You will perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently. In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry; who are truly recognised as the cornerstone of our success. We will provide you with meaningful and challenging work and the opportunity to acquire valuable personal and professional skills; through our best in class training and development. *Qualifications:* Education and Experience: • University degree in a life-sciences field • 2+ years of independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation • Demonstrated understanding of ICH-GCP, EU and FDA requirements • Fluency in English and ability to work and live in the UK • Demonstrated understanding of medical/therapeutic area knowledge and medical terminology • Exceptional communication, organizational and time management skills • Ability to work in a team or independently as required • Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. HOW TO APPLY: Please submit your CV in English. Registration on our website will also give you the opportunity to be considered for other positions if this one is not the most appropriate for your qualifications and experience. This is an on-going search. Suitable candidates will be contacted accordingly. Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law. All CRA II and above are eligible for a £10,000 joining bonus for a limited time only * #LI-_LS1 * IndeedPPDGBIE IndeedPPDEMEA *#LI-_LS1*

*Regulatory Strategist* *Summarized Purpose:* This role provides clear global regulatory advice into new drug development. This includes full end to end regulatory consultancy that delivers a Target Product Profile for products/portfolios. *Essential Functions:* * Provides strategic regulatory advice to external and internal clients including clear development and global registration pathways. * Develops and grows client base into long-term partnerships. * Acts as part of project team for appropriate projects; proactively update and adjust guidance and strategy according to changing circumstances or emerging data. * Works closely with regulatory affairs colleagues to support appropriate bidding and project execurion activities. * Uses profile and experience as differentiating factor to support the company "win" outcomes. * Shares knowledge and experience with others in RA in order to build our capacity in this area. * Interfaces with regulatory authorities to support specific policy and advocacy activities as they arise. * Analyzes available information and plans in order to effectively communicate gaps to client and account for in strategy. Proactively asks the key questions to drive such analysis and actual client needs and expectations. * Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. * Approves courses of action on salary administration, hiring, corrective action, and terminations. * Reviews and approves time records, expense reports, requests for leave, and overtime. *Qualifications:* *Education and Experience:* * Bachelor's degree or equivalent and relevant formal academic / vocational qualification * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years). * 7+ years of management responsibility * Advanced leadership skills In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. *Knowledge, Skills and Abilities:* * Consultative mindset: proactively leads with firm and clear recommendations, advice, and direction to clients. * Knowledge and experience over multiple therapeutic areas for Phase I to IV clinical development, non-clinical pharmacology, toxicology, and pharmacokinetics; chemistry, manufacturing and control; clinical protocol designs; relevant regulatory precedents for product approvals; and proven track record for successful negotiations with regulatory authorities. * Ability to clearly articulate strategy, background and context at all levels, internally and with client to C-suite level. * Outside-the-box thinking for creative solutions - with qualitative risk analysis and ability to propose a Plan B. Thinks outside the confines of the guidance and regulations. * Team player; a strong/senior contributor to the execution of agreed strategies. * Key external customer: Biotech companies likely with 1 or more global gaps in knowledge and regulatory capacity. Likely to be involve in very early engagements with client (pre-RFI, RFI) and other selling or awareness activities. Role therefore will include a degree of international travel. * Key internal stakeholders/commercial: including Business Development; Business Portfolio Leads; Biotech. * Key internal stakeholders: including Regulatory Affairs, Early Development Services; Global Product Development; GCD. * Proven and deep regulatory development knowledge in at least one of the following: US, EU (including UK), China, Japan; this will include established relationship with regulatory authorities and proven ability to clearly communicate and use regulatory insights proactively for practical drug development strategies. Likely to have 10+ years' experience in this area. * Demonstrated ability to develop and clearly communicate GLOBAL regulatory strategy, deploying global regulatory intelligence, insights and other regional experts to build robust and coherent end-to-end development and registration strategies for clients/assets. * Experience in working with and driving multi-functional teams to strategy and delivery for new assets - to include (not limited to) clinical, global product development, PK, start up, market access and Drug Development Leaders. * Previous experience working for a major regulatory authority (USA FDA, EMEA etc.) useful, but not essential. *Management Role:* Director role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of director skills and responsibilities as demonstrated by consistent, multi-year successful performance. Directs through subordinate management. In some instances, may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions. * PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: * * Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. * Able to work upright and stationary for typical working hours. * Ability to use and learn standard office equipment and technology with proficiency. * Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. * Occasional travel to site locations and frequent travel both domestic and international. *LI-SH1 *LI-SH1

Principal Regulatory Affairs Specialist We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. If you're a strategic thinker, planner and multitasker as comfortable working independently as you are on a team in delivering compliant deliverables based on solid judgment, PPD is the place to be. Our global regulatory experts contribute the regulatory strategy and knowledge to help our clients navigate the challenging regulatory environment - and help get life-changing therapies to patients faster. PPD is seeking a Principal Regulatory Affairs Specialist to join our growing Regulatory Affairs department. This is a fantastic opportunity to further your regulatory career and develop your expertise in this field. In this role you will be a pivotal team member with ideally with regulatory experience. You will provide innovative solutions including global regulatory therapeutic area expertise and client interface to provide strategic regulatory intelligence, guidance and regulatory expertise for product development from preclinical through registration and product optimization. You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients in the provision and marketing of these services. You'll work with the Regulatory Affairs management to perform the day to day operational aspects of the department such as: preparation and assembly of global regulatory submissions unassisted, interacting with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature. You will also act as prime interface with the sponsors of assigned projects. The following skills are required to be successful in this position: • Experience developing regulatory strategies globally • Experience and knowledge of bid defence meetings • Experience leading global regulatory projects • Client facing experience *Qualifications:* What the role requires you to have: • Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job • Knowledge of the global clinical trials landscape • Proven project management experience, and experience performing effectively in a client facing role Knowledge, Skills and Abilities: • Excellent command of the English language (written and oral) as well as local language where applicable • Excellent attention to detail and quality as well as excellent editorial/proofreading skills • Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments • Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies • Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects • Excellent negotiation skills • Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables • Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines • Excellent analytical, investigative and problem-solving skills • Understanding of budgeting and forecasting At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. *LI-SH1 As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

*Principal Statistical Scientist - EMEA * We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients. Our Biostatistics & Programming department are passionate about being data and technically agile, and driving enhanced value for our clients and patients. Determined to improve patient health, we help PPD provide industry-leading statistical, programming and clinical pharmacology contributions through global delivery, consistent quality adherence and scientific insight. We currently have an opportunity for an expert Lead Biostatistician to join our Statistical Science team within Biostats and Programming as a Principal Statisitcal Scientist. As a Prin Stat Scientist you will perform a statistical consulting role both internally and externally. Responsibilities include: * Serves as the lead statistician on broad-based projects or complex, multiple protocol programs as required. * Serves as the project manager for Biostatistics contracts -both stand alone and cross divisional. * Serves as the scientific and therapeutic area thought leader for study design and statistical analysis issues. * Provides scientific strategy consultation to clients for drug or device development planning. * Provides statistical input into corporate initiatives. * Maintains expertise in state-of-the-art data manipulations and statistical analyses. * Represents the department to clients on complex study scientific and design considerations, directly contributing to complex study proposals and bids, representing the department at bid defenses. *Qualifications:* *To be considered for the role, you should have the following Education, Skills and Experience:* * Master's degree in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 5 years of clinic al trial experience as a statistician; * PH.D. in statistics, biostatistics, or equivalent field with appropriate statistical coursework and at least 3 years of clinical trial experience as a statistician; * Required Knowledge, Skills and Abilities: * * Demonstrated initiative and motivation. * Excellent verbal and written communication skills. * Positive attitude and the ability to work well with others in a multi-disciplinary setting. * Strong knowledge of SAS and clinical biostatistics. * Demonstrated knowledge of the drug development process. * Conversant knowledge of FDA and other Regulatory guidances and regulations. * Demonstrated ability to manage change and uncertainty to optimize positive outcomes. * Must be able to multi task and pay close attention to detail. * Proven performance in leading complex projects. * Good organizational skills with the ability to adapt and adjust to changing priorities. * Strong theoretical background and applied statistical knowledge. * Ability to mentor statisticians with regard to scientific principles, statistical methodology, and/or knowledge of a specific therapeutic area.. * Ability to communicate complex statistical concepts in a multi-disciplinary setting. * Demonstrated knowledge in one or more therapeutic areas. At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel. - We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-AD1

PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our Project Delivery team directs, coordinates and manages the technical and operational aspects of projects, securing the successful completion of clinical trials. We collaborate with functional area leads to identify and evaluate fundamental issues on the project and ensure that solutions are implemented. The *Project Manager/Senior Project Manager - Consumer Health* is responsible for the overall coordination and management of consumer health clinical trials and non-interventional studies from start up through close out activities. Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees. *Summarized Purpose: * Responsible for the overall coordination and management of of consumer health clinical trials and non-interventional studies from start up through close out activities. Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the customer's time/quality/cost expectations. Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through costs and ensuring timely invoicing with the support of Project Management Directors and/or Associate Directors while working in collaboration with other functional area leads. May work with Directors and/or Associate Directors, Project Management and Contracts & Proposals Development on the development of new proposals and general capabilities presentations to Customers for new business. *Essential Functions:* * Manages allocated studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project. Works with team and management to develop plans/guidelines for project implementation using PPD tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables (i.e., regulatory document, research agreement, site payments, interim monitoring, CRF retrieval, CRF data entry, etc.). Ensures teams are entering and updating internal tracking tools e.g. Project Pulse, CASCADE, etc. Works with team to identify potential risks, develop contingency plans * Acts as principal liaison between Sponsor and PPD by facilitating the flow of information between PPD and client. Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. May discuss and obtain feedback from Sponsors regarding PPD's performance to date * Plans and communicates to team members study specific tasks and priorities for projects. Delegates, as appropriate, assigned responsibilities to project team members. Liaises with managers in all functional areas within PPD to optimize performance and utilization of the project team members. Appropriately escalates any issues or potential issues to the Project Management Director or Associate Director for all project related issues * Works closely with finance and legal to manage all financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices, establishing proper accrual for investigator grants, assisting with negotiation of the investigator grants as needed and similar pass-throughs * Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets. Works closely with Project Management Director or Associate Director to provide details for the development and negotiation of contract modifications, as needed. Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed * Provides input into hiring, performance management, training and other activities related to leading project staff members across functional areas. * Works to prepare and present at client meetings as the assigned Project Manager. Attends bid defenses as necessary. #LI-HS1 #LI-Remote *Qualifications:* *Education and Experience: * Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years' for Sr PM level) or equivalent combination of education, training, & experience. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. *Knowledge, Skills and Abilities: * * Knowledge of the key principles of cross functional project management (Time, Quality, Cost). * Solid financial acumen. * Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen. * Can effectively plan and deliver a dynamic and persuasive presentation, using effective graphics, overheads or slides. * Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written). * Sound interpersonal skills, is flexible and adapts to changing situations. * Has the ability to persuade, convince, and influence or impress others. * Is organized, proficient at multi-tasking with good attention to detail * Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate. * Able to delegate, effectively prioritizes own and workload of project team members. * Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. * Possesses cross cultural awareness and is able to adapt appropriately. * Has an in-depth understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology. * Has experience with leading, liaising and coordinating cross-functional project teams. * Has an in-depth knowledge/understanding of clinical development guidelines and directives *PPD Defining Principles: * - We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing - We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you.

Our Project Delivery team directs, coordinates and manages the technical and operational aspects of projects, securing the successful completion of clinical trials. We collaborate with functional area leads to identify and evaluate fundamental issues on the project and ensure that solutions are implemented. We have a new opportunity in our *Hematology/Oncology Project Delivery Team*. This role is for a *2nd level People Manager.* The position will be at *Senior Director level* and manage a team of People Managers whio manage a team of Project Managers leading delivery of Hematology/Oncology projects. This can be based anywhere in the EMEA region and can be office or fully remotely based. You will be an active member of the Hematology/Oncology People Management team with contributing responsibility for developing Project Management performance in the team, providing input towards optimising performance, support to our growing delivery team and related departmental activities. * Role overview * This role will include all aspects of people management, engagement and development, including preparing and conducting performance calibrations, reviews and salary reviews; ensuring compliance with company policies alongside being accountable for Project Leaders to ensure successful execution of all project deliverables within assigned project(s) and supporting individuals in their chosen career pathway. You may also represent Hem/Onc in cross-functional activities and initiatives. *Qualifications:* * Education and Experience: * * Bachelor's degree or licensed certified health care training or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities. * Recognised ability to effectively develop and implement strategies across a large team. * Experience and competence in managing, coaching and leadership of managers is highly desirable. * Relevant experience within Project Management. * Proven line management skills preferred * Demonstrated expertise in leading, developing, motivating and integrating senior teams and empowering others for success. * Understanding of client and project oversight and commercial expectations is highly desirable. * Proven judgement and decision-making skills, combined with excellent interpersonal and problem-solving ability. * Effective organizational and negotiation skills. * Excellent networking skills and able to liaise with other Divisions/Departments where necessary. * Strong business and financial acumen; ability to trouble shoot operationally, budgeting, forecasting and resource management. * Self-motivated and possess good interpersonal skills and a demonstrably positive attitude. * Ability to effectively teach required skills, combined with proven coaching and mentoring skills. * * PPD Defining Principles: * We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing - We are one PPD If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-Remote #LI-MC2

PPD's mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our Project Delivery team directs, coordinates and manages the technical and operational aspects of projects, securing the successful completion of clinical trials. We collaborate with functional area leads to identify and evaluate fundamental issues on the project and ensure that solutions are implemented. We have an opening for an *(Associate) Director in our Project Management Team* in the EMEA region. This sits in the *Vaccines Group* and will wokr as *Oversight for Vaccines studies*. The role can be fully homebased or office base at any of our EMEA offices. The AD/Director, Project Management provides strategic direction, leadership and management across multiple divisions to direct the delivery of projects/programs within cost, time and quality requirements. Works globally with other groups to develop new business and to deliver existing business. Responsible for achieving overall financial goals (sales/repeat business, revenue and profitability). Works with leadership in all functional areas on the continuous development/improvement of business processes to support cross functional teams and to ensure that work is uniform, complete and managed appropriately. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees. *Role overview: * Provides strategic direction, leadership and management across multiple divisions to direct the delivery of projects/programs within cost, time and quality requirements. Works globally with other groups to develop new business and to deliver existing business. Responsible for achieving overall financial goals (sales/repeat business, revenue and profitability). Works with leadership in all functional areas on the continuous development/improvement of business processes to support cross functional teams and to ensure that work is uniform, complete and managed appropriately. This position may be responsible for directing and leading the activities of Vaccines area within a Region and accountable for the P&L of a specific therapeutic area. Develops and drives the specific and overall therapeutic area strategies to ensure optimum performance and achievement of annual plans and targets. Has overall responsibility for instigating and leading change initiatives within the therapeutic area and works with peers of the Vaccines areas in the overall leadership of the Project Management group. * Key responsibilities * Ensures the timely execution of clinical trials with a focus on quality deliverables and profitability. Facilitates hand-off meetings and kick-off meetings to identify potential risks and work with the project team to develop and communicate contingency plans. Ensures project risks and potential contingencies impacting time/quality/cost of deliverables are discussed with Senior Management through appropriate escalation pathways. Reviews and assesses project profitability through the identification of "out of scope" activity in a timely manner and supporting follow through on all aspects of contract modification. Manages the overall budgeting activity of the groups - annual and long range forecast. Serves as the Customers' "Executive" contact person for all issues. Communicates with sponsor(s) regularly to obtain direction and feedback on implementing scope of work as well as performance to date. Identifies unusual or significant problems encountered during the course of a clinical trial and proposes strategies for preventing or correcting significant problems. Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the location/division at appropriate professional meetings and conferences. Fosters client relationships and supervise strategic sell initiative of the division. *Qualifications:* * Education and Experience: * * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years) or equivalent and relevant combination of education, training, & experience. * 7+ years of management responsibility * Advanced leadership skills * Vaccines experience Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. * Knowledge, Skills and Abilities: * * Strong leadership skills. * Strong financial acumen. * Excellent judgment and decision making skills. * Effective oral and written communication skills including the ability to communicate in English, both orally and in writing. * Excellent interpersonal skills and problem solving ability. * Effective organizational skills and negotiation skills. * Expert knowledge of project management principles and application. * Knowledge of budgeting, forecasting and resource management. * A relationship builder who is able to work effectively in matrix organizations. * Knowledge of regulatory guidelines and Directives. * Skilled in process improvement, especially as it applies to clinical trials, clinical development and project management. * Knowledge of medical therapeutic area and medical terminology. * Strong marketing skills. * IT skills. *PPD Defining Principles: * - We have a strong will to win - We earn our customer's trust - We are game changers - We do the right thing - We are one PPD If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. #LI-MC2 #LI-Remote

Summarized Purpose: Works with the Clinical Data Manager and Database Programmers in the efficient implementation of each clinical study database into production. Provides leadership role in the development of the study build and edit check design and specifications. Essential Functions: * Leads development of Clinical Study Design and Specification documentation to support efficient Database Build/UAT * Leads development of Clinical Study Edit Check Specification ocumentation to support efficient Edit Check Programming/UAT * Leads/Participates in development of complex Database Modification Request * Specifications, as determined by the DM Global Teams * Consults with Clinical Data Manager and Database Programmers during Clinical * Database Start-Up Process on design/Specification questions * Understands and follows departmental and corporate WPDs and SOPs, and contributes to their development as needed *Qualifications:* *Qualifications*: Education and Experience:Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, and experience. *Knowledge, Skills and Abilities:* Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines Excellent customer focus and interpersonal skills Proven flexibility and adaptability when working in a team and independently using good judgment in making decisions Good computer skills and knowledge of relational databases and interactive computer programs Good written and verbal communication skills Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law. #LI-GG1

*Medical Information Specialist with Italian - United Kingdom* PPD is looking for medical information specialists for its growing Medical Communications department. Start a career you will enjoy! Join a team of energetic healthcare professionals supporting one or more pharmaceutical/biotech companies. As a front-line specialist in our medical information contact center you will represent PPD and the client(s) by providing concise, accurate and non-promotional information regarding the client's medicinal products or devices to healthcare professionals and patients. Your typical day consists of : * Receiving medical information enquiries through various communication channels and documenting them in the appropriate database * Triaging and responding to the medical enquiries using client approved resources * Identifying, capturing, reporting, and following up on adverse events and product complaints in compliance with established timelines and organizational, client and regulatory guidelines * Maintaining and demonstrating advanced knowledge of project and corporate policies and procedures * Attending team and client meetings * Performing assigned peer quality reviews * Performing other ad-hoc activities according to PPD and client procedures *Qualifications:* What is required? * A degree in a scientific discipline or life science degree e.g. Medicine, Pharmacy, Nursing, Biology, Psychology, Veterinary medicine or similar * Fluency in Italian and English * Capability to efficiently use computer systems (hardware and software) * Organizational and time management skills * Attention to detail * Customer service oriented - compassionate, empathetic, patient * Ability to work independently as well as part of a team * Ability to maintain a positive and professional manner in challenging circumstances What we offer? * Competitive corporate benefits package, including health and dental insurance and various retail discounts * Well organized onboarding and training period, with extensive support from experienced medical information specialists and the management team * Opportunities to take additional training and responsibilities if you would like to expand your skillset and boost your career development * Genuinely friendly, helpful, cooperative, and supportive multicultural team environment * A great work-life balance * PPD Defining Principles * : - We have a strong will to win - We earn our customer ' s trust - We are gamechangers - We do the right thing -We are one PPD - If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you * Start your job application: click Apply Now * #LI-AB1