Associate Director, Global Scientific and Regulatory Documentation, Content Strategy

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it. Position SummaryTo coordinate and author complex regulatory documents needed for regulatory submissions ensuring the coordination and integration of the scientific, medical, and regulatory input from development team members for assets in the immunology and cardiovascular therapeutic areas. Implements regulatory documentation standards that support speedand consistency of regulatory submissions across all full development / life cycle management assets and geographies.Key ResponsibilitiesAuthor complex clinical documents needed for regulatory submissions (eg, Pivotal Phase 3 CSRs, CTD summary documents, Pediatric Investigational Plans, Investigator’s Brochures, HA Briefing Books, responses to Health Authority queries) for timely submission to health authorities worldwide according to:good documentation principles (organization, clarity, scientific standards)consistency between text and tabular presentations or graphical displaysin compliance with BMS documentation standards and regulatory requirementsParticipate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.Prepare document prototypes, including the document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. Lead or co-lead (with Documentation Lead) teams to define content and organization for complex documents (eg CTD summary documents). Comply with internal processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure:optimal communication between authoring team and development team memberscoordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentationtimely completion and high quality of assigned documentsReview regulatory and clinical documentation according to good documentation practices (organization, clarity, scientific standards), to establish consistency of content within TA and asset, and compliance with BMS documentation standards and worldwide regulatory requirements.Facilitate proactive sharing of knowledge and key learnings within the group and across other functions.Qualifications & ExperiencePharmD/PhD/MD in a relevant scientific discipline or Master's/Bachelor's degree with approximately 10 years of pharmaceutical regulatory documentation. All PhD in biological sciences and PharmD candidates are considered.Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).Analyze and interpret complex data from a broad range of scientific disciplines.Thorough understanding of global pharmaceutical drug development and requirements for documentation authoring supporting major regulatory submissions.Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team.Working knowledge of a document management system and basic knowledge of the document publishing process.Experience in the areas of state-of-the-art documentation processes and technology.We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.Compensation Overview: Princeton - NJ - US: $170,880 - $207,061 The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance. Benefits: Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability). U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year. Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays. Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day. U.S.-based job seekers can explore full benefit offerings at