Nonclinical Regulatory Document and Scientific Writer

Job Description

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 (e.g., 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.

Duties & 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.

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.
• 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 enProducts 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.