Clinical Labeling Strategist (Manager / Sr. Manager) This role collaborates across business units and functional lines and has accountability to ensuring that Investigator’s Brochures (IBs) are created, revised, maintained, and submitted in compliance with governing SOPs and regulatory requirements. The Clinical Labeling Strategist is an extended clinical study team member responsible for ensuring the development and maintenance of all Single Reference Safety Documents (SRSDs) (both IB and non-IB) for submission to regulators, to share the known risks of medicinal products under study for all Pfizer-sponsored protocols, and for their use as the Reference Safety Information (RSI) for expectedness assessments by Pfizer’s drug safety analysts. The role will be accountable for contributing to relevant initiatives, including continuous improvement projects and technology advances to ensure effective management and delivery of all reference safety documents used in clinical trials. The role will report to the Head of Clinical Labeling & Investigator Initiation Packages (CLIIP) within Global Labeling, Artwork, and U.S. Advertising & Promotion (GLAAP). Responsibilities include (but not limited to) the following: Chairing meetings, leading team discussions utilizing subject matter and regulation expertise to establish appropriate strategy for the IB. Providing end-to-end project management of the IB deliverable, setting clear targets and ensuring all functional lines are aware of commitments, securing necessary contributions, and completing within agreed timelines. Ensuring full execution of all IB documents (initial creation and updates) in compliance with ICH guidance, regulations, and internal policies. Monitoring SRSD labels for updates to their Reference Safety Information (RSI) sections. Obtaining appropriate approvals from key regulatory and safety contributors Maintaining appropriate SRSD versions, making them availability to drug safety, and communicating them to clinical investigators and other stakeholders. Senior Manager responsibilities in addition to the above include but not limited to the following: Interpreting and advising current regulations/guidance considering the wide range of needs of various internal stakeholders. Identifying risks and leading IB contributing teams through issues and barriers to achieve timely and quality resolution. Serving as a subject matter expert for products within their scope of remit Understanding roles, responsibilities and dependencies of upstream and downstream stakeholders and deliverables. Acting as a subject matter expert for quality events, contributing to the investigation/root cause analysis and remediation actions as appropriate. Providing training and mentoring to new colleagues and any contractors/vendors involved in the process. Proactively evaluating current systems and processes and offering suggestions for improvements. Assessing external regulatory requirements, ICH guidance and performing initial impact assessment when requested. Here Is What You Need (Minimum Requirements) Education : Life sciences degree. Advanced academic qualifications/degree an advantage. (e.g. BA/BS, or MBA/MS, or PhD/JD; each with a corresponding depth of relevant experience) Manager level with proven pharmaceutical regulatory or clinical experience. Sr. Manager level with extensive pharmaceutical regulatory or clinical experience. Experience & Attributes Multiple years of pharmaceutical regulatory or clinical experience. Strong understanding of regulatory submission processes and requirements. Demonstrated attention to detail and problem-solving skills. Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures. Understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts. Excellent written and verbal communication skills essential. Proven project management skills with the ability to lead complex projects Exceptional organizational skills and attention to detail. Effective problem-solving and negotiation skills. Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance The closing deadline for applications is March 23rd. All applicants must have the relevant authorisation to live and work in the UK / EU as applicable. Purpose Breakthroughs that change patients' lives At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Regulatory Affairs