Jazz Pharmaceuticals

This role requires you to be onsite full time based at our site on Kent Science Park in Sittingbourne. Brief Description: The Associate Director, R&D - Process Chemistry heads the process research and development team within the Discovery and Medicinal Chemistry group at Kent Science Park, adopting a leadership and technical role and working together with other CMC functions to advance drug candidates from lead optimisation to GLP Tox. Essential Functions Lead a group of scientists and is accountable for the development activities in the Process Development Team. Analyse and evaluate medicinal chemistry synthetic procedures to redesign and/or identify scalable processes covering supply of early development activities up to GLP Tox. Plan, agree, resource, and execute the optimization of a synthetic route, identifying clear deliverables and milestones in accordance with the overall molecule project plan. Identify intellectual property generation opportunities and drive innovation within the team. Present regularly project updates to the department and CMC teams with a focus on prioritization and delivery. Act as the Drug Substance Lead and SME, working closely with other early CMC functions including analytical, preformulation, biopharmaceutics, Medicinal Chemistry, and toxicology. Promote a purpose-driven team environment, with a focus on safety within the department. Identify procedural and technical gaps within the department and drive implementation of optimized procedures. Required Knowledge, Skills, and Abilities Relevant pharmaceutical industry experience within a Discovery/Early Development setting with a broad understanding of early drug development and drug candidate nomination criteria. Good understanding of key attributes that make a potential drug suitable for IND-enabling / clinical development. Ability to survey scientific literature broadly beyond own discipline. Excellent management skills, including planning and resource allocation. Excellent verbal and written communication skills, including effective communication with external partners. Strong IT skills and ability to use key software packages for data production, presentation, and analysis. Demonstrated ability to lead projects from inception to completion, coordinating efforts within budget, timelines, and regulatory requirements. Partner with Pharmaceutical Development on API development approaches to mitigate risk as candidates progress. Display attributes aligned with Jazz's values, encouraging their development in others. Required/Preferred Education and Licenses MSc/PhD in a chemical or pharmaceutical subject, ideally with postgraduate qualification in chemical synthesis, drug substance development, or related discipline. Knowledge of quality and regulatory standards within the Pharmaceutical Industry in early phases and experience applying those into drug development projects. cGxP awareness and experience applying this within an R&D environment. Ideally, experience with statistical procedures and software, particularly DoE and multivariate analysis.

We are seeking an enthusiastic and detail-oriented HR Advisor to support the HR Delivery Team in executing HR initiatives across multiple regions. This role is essential in ensuring the smooth delivery of core people processes and employee relations. The ideal candidate will have strong interpersonal skills, a willingness to learn, and the ability to collaborate effectively with various HR teams. This role will also provide coaching and guidance support to people managers across the business to enable proactive people outcomes across the complete employee lifecycle. Essential Functions/Responsibilities Employee Relations:Help manage and resolve employee relations issues, ensuring compliance with local labor laws and company policies. Management Support:Provide support to managers to enhance their leadership capabilities and ensure they are equipped to handle HR-related matters effectively. Core People Processes:Support the execution of core HR processes, including performance management, compensation planning and others Organizational Design:Assist in the execution and implementation of organizational design outcomes. Employee Advocacy:Assist in championing a culture of employee advocacy by addressing employee concerns and feedback promptly. Employee Listening:Assist in implementing and managing employee listening programs to gather insights and feedback. Data-Driven Decision Making:Utilize data and analytics to support HR decisions Team Collaboration:Work closely with People Operations, Talent Acquisition, and HR Business Partner (HRBP) teams to ensure alignment and integration of HR strategies and initiatives. Compliance:Ensure all HR activities comply with relevant laws, regulations, and company policies. Required Knowledge, Skills, and Abilities Operational knowledge and experience in generalist HR Basic knowledge of employment laws and regulations Strong employee relations case experience Excellent communication, interpersonal, and collaboration skills Strong willingness to learn and develop in a fast-paced, dynamic environment Analytical and problem-solving abilities Proficiency in using MS Office Suite and HR software and tools is a plus HR experience working across both UK and Ireland is desirable Required/Preferred Education and Licenses Bachelor's degree in Human Resources, Business Administration, or a related field.

This is a remote role Summary The Medical Affairs Director will lead the development and execution of the Europe and International (EUR/INT) Medical Affairs GEA strategy. They will work with the Senior Medical Director and support them in developing the Scientific Strategy. This role critical to the future success of the organisation. As a key member of the EUR/INT Therapy Area Brand Team, the role will demand high levels of cross functional collaboration. The incumbent has responsibility for ensuring all activities are executed in accordance with regulatory and legal frameworks including but not limited to ABPI, EFPIA and GCP regulations as well as Jazz Pharmaceuticals Policies and Healthcare compliance procedures. Essential Functions Review and critically appraise scientific literature to identify key drivers that differentiate Jazz in GEA and work with cross functional members to create the overall brand strategy and tactical implementation plans Ensure the EUR/INT KOL and educational activities are of a high scientific quality and coordinated The incumbent will develop and maintain a high level of knowledge of GEA and related diseases in order to position him/herself as an expert in the field Act as GEA subject matter expert and facilitate knowledge transfer to country medical teams and country commercial teams Lead and contribute to the regional understanding o f the competitive landscape in GEA and communicate intelligence to the medical and marketing team as appropriate Lead the team in the creation of training material and other scientific materials in collaboration with marketing and other appropriate internal stakeholders As a scientific authority support the associate medical director(s) in their review and approve medical content in promotional and non- promotional materials Strategic and Tactical Planning Lead t he development and implementation of the EUR/INT medical affairs GEA strategy aligned to commercial growth drivers Data Generation and Publication Planning Lead development of GEA IEGP / publication plans ensuring that the needs of the EUR/INT data generation are covered Lead the publication of customer initiated data or reviews in line with Jazz GEA strategy Obtain the approval and implementation of these projects in line with relevant pharmaceutical regulations and Jazz SOPs as appropriate Lead the development and execution of GEA study plans to provide post marketing data to support the portfolio External Relationships Guide & support the solid tumor team to interact and liaise with national and international KOLs in the field of GEA Guide & support development of EUR/INT KOL advocacy through provision of scientific and clinical information with the regional and country teams Deliver non-promotional clinical/scientific presentations relating to Jazz's GEA portfolio and its development or differentiation as required Attend appropriate scientific congresses to stay abreast of developments as agreed by the senior medical director, soild tumour Required Knowledge, Skills, and Abilities Able to understand the detailed science and clinical aspects of the Solid Tumour portfolio Excellent presentation skills, strong interpersonal skills Excellent command of spoken English Proven track record of launching new products in Specialty medicine, preferably in Solid Tumour Strong communication skills to facilitate collaboration at all levels of the organisation as well as with external customers Able to demonstrate clear understanding and experience of competitive study design and execution Willingness to travel frequently Excellent work ethic and demonstrates ability to matrix manage and work well in a cross functional team Proficiency in computer skills Experience in medical affairs, including regional experience Required/Preferred Education and Licenses Strong preference for a medical doctor/pharmacist, ideally with experience in Solid Tumour PhD or higher science degree Preferred medical affairs experience Experience of working in a regional medical affairs role is highly desirable Good understanding of healthcare systems and the needs of payors

If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. Brief Description: The Clinical Trial Specialist (CTS) will be a member of the Jazz Pharmaceuticals Clinical Operations team. They will have the following key responsibilities: Support moderately complex clinical study activities in support of the Clinical Trial Manager. Work closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. May assist with vendor oversight and management with guidance. Identify issues in a timely manner and escalate to management as appropriate. May complete monitoring visit report review and perform co-monitoring or monitoring oversight visits. Essential Functions: Support Phase 1, 2, 3 and 4 clinical studies with guidance. Support activities related to study/site feasibility, start-up, maintenance, and close-out. Manage study and site essential document review, collection, tracking, etc. from study start-up through maintenance and close-out. With guidance, support the Study Lead (CTM, AD, etc.) to prepare and maintain study documents and manuals as applicable (including but not limited Informed Consent Forms, study manuals, site materials, training materials, pharmacy, and laboratory related manuals, etc.) Study Trial Master File (TMF) oversight. Ensure required study documents received, reviewed, and filed in the TMF in accordance with SOPs, GCP and applicable regulations. Organize study related meetings including but not limited to preparation of agenda/ minute taking and maintenance of risk/ issue/ decision logs. May lead and present at study related meetings. May perform applicable site monitoring / co-monitoring visits (ad hoc, pre-study, initiation, routine monitoring close-out visits). Provides rapid action to address both internal and site QA findings from audits. May manage, coordinate, and oversee the activities from third party vendors including deliverables metrics, accruals, process planning, and implementation. General study tracking and maintenance, includes but not limited to study status, enrolment, sites queries, deviations, study levels documents and plans, etc. Study site oversight including but not limited to site performance, metrics, monitoring report review, etc. Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc. Routinely support and participate in department and clinical trial team meetings and participate in collaborative efforts (e.g., protocol development, CRO selection, departmental initiatives, etc.). Work cross-functionally and provide oversite of CRO and vendor activities, including vendor management as assigned. Review and verification of contracted vendor activities including vendor invoice review. Support study reporting and tracking with applicable systems and technology. Support study leads in cross-functional alignment of study timelines. Required Knowledge, Skills, and Abilities: At least 2 years of experience (3yrs preferred) in clinical studies (Pharmaceutical Industry Experience Preferred). Previous site monitoring or study coordinator experience is preferred. Working knowledge of Good Clinical Practices (GCP) regulations and Standard Operating Procedures. Understanding of study phases and general knowledge of how they apply to clinical development. Demonstrated ability to work independently and in a team environment. Advanced knowledge of Word, Excel, and PowerPoint. Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet, SharePoint, etc.). Knowledge of the principles and practices of computer applications in database management. Strong verbal and written communication skills required. 10% - 20% travel may be required. Required/Preferred Education and Licenses: BA/BS, nursing degree or equivalent required, science major preferred. Relevant clinical trials experience is preferred. Jazz Pharmaceuticals is an Equal Opportunity Employer.

The Senior Manager, Global Regulatory Affairs will be responsible for managing registration and regulatory support for commercial and development projects worldwide.Essential Functions:Manage regulatory activities to maintain EUR and INT commercial licenses.Support EU and global clinical trials.Support development and implementation of regulatory strategies to facilitate the progress of programs through all phases of development, under the supervision of GRA leadership.Through the performance of risk assessments, work with GRA leadership to identify and communicate potential risks associated with strategy scenarios to the multi-disciplinary team.Act as regulatory representative at meetings with business partners and regulatory agencies.Plan and co-ordinate the writing and reviewing for relevant sections of regulatory submissions (IMPDs, CTAs, MAAs, meeting requests, and briefing documents), as appropriate.Coordinate the preparation and timely submission of responses to regulatory agencies.Manage timelines to ensure approvals are timely and development objectives are met.Monitor Global regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.Verify electronic publishing of regulatory submissions.Identify & support continuous improvement opportunities for the broader GRA team.Ensure compliance with company policies, procedures and training expectations.Required Knowledge, Skills, and Abilities:Demonstrated understanding and strategic application of regulations and guidelines for drugdevelopment.Solid working knowledge of regulatory and ability to generate clear, well-argued positions.Must have experience with electronic Common Technical Document regulatory documents(MAA, BLA, responses and CTAs/INDs).Demonstrated understanding of EMA and ICH guidelines.Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinaryteam, as well as with external partners and regulators.Required/Preferred Education and LicensesBachelors, Masters or advanced degree in a scientific disciplineEnglish language - written and verbal communication skills.Description of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery.Some travel required.Description of Work Environment:Work indoors in normal office environment with little exposure to excessive noise, dust, fumes,vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel.Jazz Pharmaceuticals is an Equal Opportunity Employer.

The Senior Manager, Regulatory Affairs Labeling Operations will be responsible for regulatory support (both technical and operational) in the area of product labeling for Jazz Pharmaceuticals. This position reports to the Associate Director, Labeling Operations and will be responsible for the creation and maintenance of regulatory text within printed labeling materials throughout the product lifecycle, with primary focus on packaging and artwork for products marketed globally. This role will help maintain controlled records for present and historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation. As needed, the Senior Manager will also support the implementation process improvement changes to increase the efficiency and effectiveness of the label review process. This position will interact with Regulatory Affairs colleagues and interact cross-functionally with members of the Commercial, Quality, and Supply Chain organizations.Essential FunctionsMaintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementationRepresent Labeling function within change control management of printed materialsSupport assigned team(s) by leading activities to ensure timely and compliant implementation of printed labelling materials (for both new commercial products and as a result of labeling variations and regulatory filing activities from a labeling perspective)Manage collaborative and solution-focused communication among all stakeholdersSupport the process for linguistic review and translation of label contentMaintain a current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to product labeling. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or process changes as needed.Develop and provide metrics and reports related to labeling operational processes and systems to leadership and key stakeholders, as requiredManagement of product information on corporate labeling webpages, as well as participating in audit and inspections as required.Assist in implementing process improvements to increase the efficiency and effectiveness of the label artwork process.Responsible for labeling implementation into printed materials, to ensure that labeling documents are produced in a timely manner according to internal SOPs and external regulatory requirements.Responsible for proofreading and departmental QC work.Lead and manage more junior labeling roles as required.Required Knowledge, Skills, and AbilitiesExperience in the pharmaceutical industry, with direct experience in Global Labeling or in other regulatory affairs function(s).Proven experience in regulatory affairs with particular focus on labeling. Experience associated with global product labeling regulations strongly desired.Strong judgement and decision-making skills.Excellent verbal and written communication skills and collaborative interpersonal skills.Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies.Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism.Ability to travel occasionally - approximately 10-20% regional and/or international travel.Responsibilities may require working outside of "normal" hours, in order to meet business demands.Required/Preferred Education and LicensesBachelor's degree required (Scientific discipline preferred) (or equivalent industry related experience)Jazz Pharmaceuticals is an Equal Opportunity Employer.