Associate Director Scientific Writing

Bristol Myers Squibb; Madison (NJ); On-site; USD 110,000 - 160,000; Full time

Job summary

Bristol Myers Squibb, based in New Jersey, seeks a translational development writer to produce biomarker reports and regulatory documents and to support publications for regulatory submissions. The role collaborates with TD scientists globally to ensure timely delivery of manuscripts, abstracts, and briefing materials.

The incumbent will help craft translational sections for submissions, coordinate with cross-functional teams, and contribute to scientific communications across disease areas.

Qualifications

• Writes scientific documents including biomarker/regulatory reports.
• Supports abstracts, posters, manuscripts and other scientific communications arising from the group.
• Collaborates with global TD teams to coordinate publication plans and life-cycle activities.

Responsibilities

• Ensure timely delivery for the TD writing book of work such as pre-clinical reports and Translational biomarker reports across disease areas.
• With TD scientists, establish annual publication goals, publication plan with priority rankings, and timelines for submission.
• Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory responses and queries for the TD group.
• Collaborate with TD scientists and representatives of other functions to execute publications/reports/regulatory documents.
• Collaborate with TD Scientists and review data to determine appropriate formats and improve flow and clarity of narrative.

Skills

Scientific writing

Regulatory documents

Biomarker reports

Clinical pharmacology

Publications

Tools

CARA

VERITY

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.

Translational Development at BMS

Translational Development (TD) is part of the Global Research and Early Development organization in BMS and leads mid- to late-stage clinical, pharmacological, and translational research and development activities for the BMS pipeline. The Translational Development team supports the late-stage portfolio for regulatory, development and life cycle management. Translational Development at BMS has a long-standing history of scientific rigor as evidenced by our peer-reviewed publications, delivery of drug approvals, strong academic collaborations and talent development. Our areas of focus include but are not limited to Hematology, Oncology, Immunology, Cardiovascular and Neuroscience. This group integrates scientific learnings from the lab and clinic as well as business insights of multiple functions and leads the development of translational strategies at the franchise level.

Position Summary

Reporting to the Program Management Lead, the incumbent will be part of the late development translational group based in NJ and will be responsible for writing scientific documents including biomarker reports, regulatory documents (eg, non-clinical summaries, translational portions of clinical/pharmacology summaries, briefing books, CSRs, investigator brochures) in conjunction with Translational scientists. This individual will also contribute to abstracts, posters, manuscript and other scientific communications arising from the group.

Technical Skills

• In-depth understanding of hematological malignancies or solid tumors or Neuroscience disorders especially the clinical landscape, evolving therapy, competitive scenarios
• Strong understanding of clinical, translational and mechanistic data with BMS assets and novel agents
• Strong background in writing and in communication strategy development, disease and or brand planning, regulatory documents preparation for in-line and late-stage development compounds
• Familiarity and working knowledge of CARA, VERITY or other documentation systems
• Understanding of late-stage drug and translational development processes
• Proven ability to work with global disease teams to develop strategies to support life cycle management efforts tailored to regional markets (i.e, US, EU, CAN)
• Strong verbal and written communication skills with experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses
• Ability to synthesize complex scientific and business problems into strategy and tactics
• Basic understanding of IP, contracting terms and provisions

Responsibilities

• Ensure timely delivery for the TD writing book of work such as pre-clinical reports, and Translational biomarker reports across the disease areas
• In conjunction with TD scientists, establish annual publication goals, publication plan with priority rankings, and estimated timelines for submission, with focus to ensure all deadlines for regulatory submissions/requests are met. Routinely interact with TD Program Manager(s) on status of publications
• Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries for the TD group in conjunction with biomarker lead(s)
• Collaborate with TD scientists and representatives of other functions (eg, Clinical, Non-Clinical Development, Pharmacology, Drug Metabolism & Pharmacokinetics) as needed to execute publications/reports/regulatory documents
• Collaborate with TD Scientists and review data to determine the appropriate tabular and textual formats to ensure clarity, logic and order of presentation. Provide suggestions to improve flow and clarity of narrative and presentation of data