Job Description
Title: Scientific Writer – Translational Development
Location: Madison, NJ (Onsite/Hybrid: 50%)
Duration: 12+ months
Hours: Mon-Fri 8am-5pm
Overview:
- A background as a scientist is considered a strong advantage, given the complexity of the reports.
- Author and contribute to nonclinical regulatory documents, including Biomarker documentation, Summary reports, Manager scripts and Scientific abstracts.
- Support disease and brand planning through strategic scientific content development.
- Collaborate closely with the Medical Communications group to ensure alignment and consistency.
- Produce highly technical reports that meet regulatory standards and internal expectations.
- Work within and across documentation systems, including those used by teams such as Cara and Verity Influence cross-functional partners.
Top Requirements:
- 8-10 years of scientific or regulatory writing experience.
- 5+ years of experience in the drug development/pharmaceutical industry.
- Experience utilizing CARA, VERITY, and other writing tools.
- Experience with publishing regulatory documents; interacting with Health Authority related submissions.
- Masters or PhD in molecular biology or oncology or other scientific disciplines.
Job Summary:
- Reporting to the Program Management Lead, the incumbent will be part of the late development translational group based in Giralda Farms 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, manuscripts, and other scientific communications arising from the group.
- In-depth understanding of hematological malignancies or solid tumors or Neuroscience disorders especially the clinical landscape, evolving therapy, and competitive scenarios.
- Strong understanding of clinical, translational and mechanistic data with Client assets and Client 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 in disease areas, preferably in hematology.
- Familiarity and working knowledge of CARA or other documentation systems.
- Understanding 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.
- Ensure timely delivery for the TD 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 TD scientists, establish annual publication goals, publication plans 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 Heme 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.
- 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 new writers as needed.
Qualifications
- Masters or PhD in Hematology/Oncology/Neuroscience or related field with 6-8 years in industry or an academic setting.
- Ability to manage scientific collaborations and projects.
- Ability to interpret data and craft key communication points from tables, listings, and graphs.
- Ability to clearly organize presentations of data into a clear narrative.
- Experience with regulatory submissions (eg, IND, NDA/sNDA) required.
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