Associate Director, Scientific Writer, Hematology TMDT, Summit, NJ

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At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Bristol Myers Squibb is an integrated global biopharmaceutical company engaged primarily in the discovery, development, and commercialization of novel therapies in the areas of hematology/oncology, cardiovascular and inflammatory diseases through innovative small molecule, biologicals and cell therapy approaches.

BMS R&D is at a critical and exciting phase of development. As it expands and integrates its portfolio with recent and exciting new acquisitions, there is an opportunity for a science-driven, dynamic and ambitious individual to aid in leading our writing efforts as part of the Hematology Translational Medicine group at our site in Summit, New Jersey.

Hematology Translational Medicine at BMS

Translational Medicine (TM) 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 hematology pipeline. The Translational Medicine team supports the late-stage portfolio for regulatory, translational development and life cycle management. Translational Medicine Hematology 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 multiple myeloma, acute myeloid leukemia/MDS, lymphoma and erythroid disorders. 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.

Summary 

Reporting to the Head of Program Management, Hematology Translational Medicine, the incumbent will be part of the late development translational group based in Summit, 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 and/or solid tumors especially the clinical landscape, evolving therapy, competitive scenarios
• Strong understanding of clinical, translational and mechanistic data with BMS assets and novel agents in hematology   
• 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 in  disease areas, preferably in hematology
• Familiarity and working knowledge of CARA 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 Heme TM writing book of work such as pre-clinical reports, and Translational biomarker reports across areas of focus (eg, multiple myeloma, lymphoma, myeloid, erythroid disorders)
• In conjunction with TM scientists, establish annual publication goals, a pan-heme TM 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 TM Program Manager(s) on status of Heme publications
• Supports regulatory submissions, regulatory interactions, writes translational sections for regulatory response and answers to regulatory queries for the TM group in conjunction with biomarker lead(s)
• Collaborate with Heme TM 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 TM 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
• Engage with Writers and other functions (eg, SciCom, Regulatory, Medical Affairs, Clinical, NCD) outside of TM as needed to stay current on writing SOPs, platforms, resources, and company guidelines
• Communicates regularly and prepares and makes presentations within the department and externally as required
• Participate in recruitment and hiring of new writers as needed

Qualifications

• Masters or PhD in Hematology/Oncology or related field with 6-8 years in industry or an academic setting
• Strong background in cancer biology, especially hematological cancers       
• Ability to manage scientific collaborations and projects
• Proven written and oral communication skills
• Ability to interpret data and craft key communication points from tables, listings, graphs
• Ability to clearly organize presentations of data into a clear narrative
• Experience with regulatory submissions (eg, IND, NDA/sNDA) required
• Effective team building and teamwork skills with multiple functions
• Detail-oriented with the ability to identify and implement creative solutions
• Ability to prioritize and manage time efficiently

Other Attributes

• Highly detail-oriented with excellent record keeping and organizational skills
• Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast-paced dynamic environment
• Able to anticipate problems at project level

• Proven track record of scientific approach to complex problem solving
• Demonstrate in-depth, scientific-directed, innovative thinking
• Recognizes interrelationships of facts/factors, processes, and systems
• Recognize risk and propose contingency plans
• Independently (or using collaborations) develop scientific direction for assignments 
• Recognize cross-functional issues
• Communicates within the larger organization
• Develops constructive relationships across organization to achieve the goals of the function and the business through leadership roles on cross-functional/divisional teams
• Communicates within the larger organization and external community
• Provides expert guidance to multi-disciplinary teams and senior management

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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