Thermo Fisher Scientific Inc.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. We are currently looking to hire: Customer Success Manager Department: Product (SAAS) Reports to: Head of Account Management Location: UK - Hybrid, primarily remote with some time in our central London office Role Objective: H ighly motivated, confident, and naturally inquisitive CSM for our Vantage platform. Track record of supporting accounts in Pharma/Medical Devices/MedTech companies. W orking collaboratively with Head of Account Management, Account Leaders and the Product team, you will utilise established account management and customer success techniques to cultivate strong client relationships, encourage commitment to their subscription product and maintain and grow existing business. Responsibilities Include: Ensure that all Vantage clients are provided with core training in accordance with contractual agreements. Design, develop, and implement a Vantage training programme to enhance the skills of clients in using the platform. Manage the Vantage support desk, adhering to SOPs Provide regular updates to clients on the progress of Vantage and its development roadmap Develop open and effective channels of communication with each client Become a reliable point of contact for key users that is required to establish a strong business relationship Listening to and understand client needs and addessing client concerns Provide market feedback to the Product Team regarding competitive offerings and client needs or positive testimonials Support Account Leaders with the renewals process and account strategies/tactics Play an active role in securing upgrade opportunities (additional users, modules, sites) Account Manage at least 2 clients yourself, including the renewal process Continually develop your own knowledge and skills in line with Vantage product and service lines, including all datasets offered, as well as maintaining a knowledgeable understanding of developments affecting the healthcare and/or pharmaceutical industry. Complete all daily, weekly, monthly administration in a timely manner as required Maintain excellent verbal and formal communication skills, critical reasoning skills and the ability to sell & negotiate effectively. Be customer-orientated. Experience: Minimum of 2 years of B2B experience in a customer success/client relationship role, ideally within the healthcare or pharma industry Experience working with, analysing and interpreting NHS datasets such as the Hospital Episode Statistics (HES) data. Experience of training users on a SaaS product Experience in managing a helpdesk Experience or interest in the healthcare and/or pharmaceutical sector Track record of delivering upgrades and increasing account value and/or retention rates Personal skills and qualities: Highly approchable manner with the ability to build rapport and relationships with clients quickly and act as the face of the company A high level of drive and resilience, with an ambitious, results-driven, and self-motivated personality Planning and organisational skills, proactive nature Great listening skills, inquisitive with a desire to learn Product and data enthusiast, aptitude for understanding data-based solutions Excellent communication and exceptional interpersonal skills Adaptable to a fast-paced high volume and high velocity sales organisation Good IT skills are essential Education Degree or equivalent ideally in Life Sciences or similar ABPI Code of Practice knowledge and exam (ideal but not essential) About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,improving patient health through diagnostics orthedevelopment andmanufacture of life-changing therapies, we are here to support them. Our global teamofmore than 100,000colleaguesdelivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit . Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Regulatory Affairs Manager Swindon, UK/Full time Work Schedule Standard (Mon-Fri) Job Description Responsibilities: Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in moulding our regulatory strategies! Perform regulatory surveillance Assess regulatory feasibility of any new request (primary focal point) and address local impact. Establish centre of expertise to be shared within Thermo Fisher network. Externally, participate to working groups within professional bodies. Supervise the maintenance of all official authorisations (MIA human and veterinary & MIA IMP - MS - ISO - GMP certificate) and establishment master documentations (SMF - DMF - device technical file) collaborating with appropriate regulatory agencies. Ensure inspections & key audits readiness and/or participate. Responsible for archiving official documents. Supervise the maintenance of regulatory data bases (Client product registration information, components). Ensure integration of registration information into Production and Quality master documents (process and QC specifications). Participate to the Change Control process by defining regulatory requirements. Acknowledge regulatory quotations and follow-up on invoices for reporting of financial indicators. Identify areas of regulatory business opportunities (PDS and others). Provide regulatory guidance (strategy definition, requirements assessment). Coordinate the authoring of CMC/Quality documentations (gap analysis, IND-IMPD, NDA/BLA-MAA, registration questionnaires, pharmaceutical declarations) and review. Supervise Client registration life-cycle activities (renewals, MoH questions). Requirements: To be successful in this role, you must possess experience in regulatory affairs, particularly within the legal framework. You should have: B.Sc. or equivalent experience in Pharmacy, Chemistry, or Microbiology, or related science A minimum of 7 years hands-on theoretical and practical regulatory affairs (including filling activities) as well as site regulatory compliance activities. UK, European, US & International main pharmaceutical regulations (including GMPs). Knowledge of the workings of UK Ministry of Health. Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements Dynamic, self-motivated, pro-active approach to taking on challenging assignments. Strong communication and collaboration skills Ability to work with critical timelines. Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans. We offer a range of flexible benefits including Pension and Healthcare in addition to competitive salaries.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Regulatory Affairs Manager Swindon, UK Full time Responsibilities: Perform regulatory surveillance Assess regulatory feasibility of new requests and address local impact Establish a centre of expertise shared within the Thermo Fisher network Participate in external working groups within professional bodies Maintain official authorisations and master documentation in collaboration with regulatory agencies Ensure inspection and audit readiness Archive official documents Maintain regulatory databases and ensure data integration into production and quality documents Participate in Change Control processes by defining regulatory requirements Manage regulatory quotations and invoice follow-up Identify regulatory business opportunities Provide regulatory guidance and strategy Coordinate and review CMC/Quality documentation Supervise client registration lifecycle activities Requirements: To succeed, candidates should have experience in regulatory affairs within the legal framework, including: B.Sc. or equivalent in Pharmacy, Chemistry, Microbiology, or related sciences At least 7 years of practical regulatory affairs experience, including filing activities and site compliance Knowledge of UK, European, US, and international pharmaceutical regulations, including GMPs and UK Ministry of Health operations Deep understanding of regulatory strategy, design control, cGMP, quality systems, and import/export requirements Proactive, self-motivated, and capable of handling challenging tasks Strong communication and collaboration skills Ability to meet critical deadlines Excellent written and oral communication skills with confidence to advocate proposals We offer flexible benefits, including pension and healthcare, along with competitive salaries.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. We are currently looking to hire: Customer Success Manager Department: Product (SAAS) Reports to: Head of Account Management Location: UK - Hybrid, primarily remote with some time in our central London office Role Objective: H ighly motivated, confident, and naturally inquisitive CSM for our Vantage platform. Track record of supporting accounts in Pharma/Medical Devices/MedTech companies. W orking collaboratively with Head of Account Management, Account Leaders and the Product team, you will utilise established account management and customer success techniques to cultivate strong client relationships, encourage commitment to their subscription product and maintain and grow existing business. Responsibilities Include: Ensure that all Vantage clients are provided with core training in accordance with contractual agreements. Design, develop, and implement a Vantage training programme to enhance the skills of clients in using the platform. Manage the Vantage support desk, adhering to SOPs Provide regular updates to clients on the progress of Vantage and its development roadmap Develop open and effective channels of communication with each client Become a reliable point of contact for key users that is required to establish a strong business relationship Listening to and understand client needs and addessing client concerns Provide market feedback to the Product Team regarding competitive offerings and client needs or positive testimonials Support Account Leaders with the renewals process and account strategies/tactics Play an active role in securing upgrade opportunities (additional users, modules, sites) Account Manage at least 2 clients yourself, including the renewal process Continually develop your own knowledge and skills in line with Vantage product and service lines, including all datasets offered, as well as maintaining a knowledgeable understanding of developments affecting the healthcare and/or pharmaceutical industry. Complete all daily, weekly, monthly administration in a timely manner as required Maintain excellent verbal and formal communication skills, critical reasoning skills and the ability to sell & negotiate effectively. Be customer-orientated. Experience: Minimum of 2 years of B2B experience in a customer success/client relationship role, ideally within the healthcare or pharma industry Experience working with, analysing and interpreting NHS datasets such as the Hospital Episode Statistics (HES) data. Experience of training users on a SaaS product Experience in managing a helpdesk Experience or interest in the healthcare and/or pharmaceutical sector Track record of delivering upgrades and increasing account value and/or retention rates Personal skills and qualities: Highly approchable manner with the ability to build rapport and relationships with clients quickly and act as the face of the company A high level of drive and resilience, with an ambitious, results-driven, and self-motivated personality Planning and organisational skills, proactive nature Great listening skills, inquisitive with a desire to learn Product and data enthusiast, aptitude for understanding data-based solutions Excellent communication and exceptional interpersonal skills Adaptable to a fast-paced high volume and high velocity sales organisation Good IT skills are essential Education Degree or equivalent ideally in Life Sciences or similar ABPI Code of Practice knowledge and exam (ideal but not essential) About Thermo Fisher Scientific Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,improving patient health through diagnostics orthedevelopment andmanufacture of life-changing therapies, we are here to support them. Our global teamofmore than 100,000colleaguesdelivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit . Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our Global Regulatory Affairs team is expanding! We are looking for a Regulatory Affairs Lead position to work for one of our key clients. This a client dedicated role for a Regulatory Affairs Lead role: clinical expert role to support clinical trial new indications, including the early indications, early development and late development, and that can support later development. Global experience is a plus, EU CTR experience will be important. The Reg Affairs Lead will act as the lead over several countries/projects in providing innovative solutions including regulatory expertise and client interface to provide strategic regulatory intelligence, and guidance supporting product development from preclinical through registration and product optimization. They will provide strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. They will also act as liaison with internal and external clients in the provision and marketing of these services. Essential Functions: Provides senior review of regulatory documents and submissions created within or outside of the company in order to ensure high quality standards that meet or exceed client expectations, local and regional requirements. Acts as subject matter expert in providing regulatory strategy advice to internal and external clients on projects of moderate complexity. Provides internal clients with up-to-date legislation and guidance as it becomes available. Participates in project management activities to support the provision of regulatory services, and acts as liaison with internal and external clients in the provision of marketing these services. Provides matrix/project leadership, training and guidance to junior team members to support understanding of regulations, impact on study, assessment of risk, etc., and to achieve a specific goal and/or project deliverables. May provide input on performance reviews to management. Ensures adherence to project budgets, time schedules, and scope of work. Ensures compliance with relevant organizational and regulatory SOPs and WPDs. Contributes to business development activities, including project budgeting/forecasting. 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). 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: Excellent English language (written and oral) communication skills as well as local language where applicable Great attention to detail and quality as well as excellent editorial/proofreading skills Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments Strong computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects Strong 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 Strong understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; good understanding of a regulatory speciality areas, clinical, in particular Clinical Trial Applications (CTA) including proven experience in submissions according to EU Clinical Trial Regulation. Experience in Global CTAs would be an advantage. Strong understanding of medical terminology, statistical concepts, and guidelines Excellent analytical, investigative and problem-solving skills Solid understanding of budgeting and forecasting Able to preform Line Managment responsibilities What we offer: 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 Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Summarized Purpose: Oversees Facilities Operations of the 2 GCL Brussels sites, including: site services, building or equipment maintenance, space planning, and projects. Implements policies, standards, services and programs, ensuring a high level of service, quality, timeliness and cost-effectiveness. Essential Functions Manages day-to-day Facilities operations at 2 locations, including but not limited to: day-to-day Facilities operations, planned equipment repair and maintenance, site security, cleaning and reception duties. Manages local Facilities team. Coaches, trains and develops team members. Manages and supervises contractors and the execution of planned maintenance and contracted services. Plans and manages for equipment and building lifecycle, prepares annual budget for planned replacements (CapEx). Leads space planning and reviews space allocation. Coordinates Facilities projects such as expansions, installations of new equipment, retrofitting of space and refurbishments; manages budget and schedule. Manages procurement for Facilities department. Tracks, reviews, reports and forecasts monthly OpEx expenditures for GCL EU. Takes on-call role for REES monitoring. Attends client audits as Facilities representative. Work closely with internal and external stakeholders to achieve goals. Policy & Strategy Reviews existing and creates new policies, processes and procedures, related to Facilities tasks. Implements policies, processes and procedures, and ensures compliance. Knowledge, Skills and Abilities 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. 5+ years' experience in Lab environment required. Technical knowledge of HVAC, electrical and building construction. Relevant experience in project management. Knowledge of financial planning and management (within department). 5+ years' experience in team management. Excellent written and oral communication skills. Strong interpersonal and collaboration skills. Strong computer skills. Flexibility. Occasional outside of hours work could be required. Management Role Management of local team of approx. 5 people. Working Conditions and Environment Work is performed in a Lab environment with potential exposure to biohazard and chemical hazards. 100% office-based role, no remote working possible. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.