Senior Scientific Writer Translational Development (Hybrid Madison, NJ)

Senior Scientific Writer ? Translational Development (Hybrid ? Madison, NJ) Senior Scientific Writer

• Translational Development (Hybrid
• Madison, NJ)We are seeking a Senior Scientific Writer
• Translational Development for our global pharmaceutical client.

Reporting to the Program Management Lead, you will be part of the late development translational group 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..This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite at the client's office in Madison, NJThis is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities:

• 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 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 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 of new writers as needed

Requirements:

• 8-10 years of scientific or regulatory writing experience
• 5+ years of experience in drug development/pharmaceutical industry
• Experience utilizing CARA, VERITY, and other writing tools
• Experience with regulatory submissions (eg, IND, NDA/sNDA) required
• In-depth understanding of hematological malignancies or solid tumors or Neuroscience disorders especially the clinical landscape, evolving therapy, competitive scenarios
• Experience with publishing regulatory documents; interacting with Health Authority related submissions
• 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.
• 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)
• Experience in developing written documents such as primary manuscripts/publications/reviews, disease strategies, mechanism slides, regulatory submissions, strategic communications, literature/market/pt segment analyses
• Masters or PhD in molecular biology or oncology or other scientific discipline