Job Description
Title: Sr Regulatory Writer – R&D
Location: Park Ridge, NJ area
Schedule: M-F Full Time
Type: Direct Hire
Responsibilities:
Our client is seeking Regulatory writing support for New and Existing Product Development (NPD/EPD) pipeline for products in the drug (OTC, DIN, NHP), medical device, cosmetic, disinfectant (EPA, DIN) and general household products areas. The Senior Writer will lead and drive the technical (CMC) writing to accelerate the development of small molecules, combination drug/device products, and other innovative materials for areas with high unmet medical needs.
- Coordinating reporting needs with project teams, regulatory strategies, and product development timelines. The incumbent will build out the technical capabilities of the R&D team by implementing best practices for report writing, documentation, and drug development expertise.
- Prepares and/or assists in the coordination and preparation of scientific documents under minimal supervision to meet or exceed quality standards.
- Drafts eCTD written and tabulated summaries, investigator brochure content, FDA briefing packages, and other agency related technical documents, in collaboration with Regulatory teams.
- Leads the compilation, writing, and editing of high-quality module 3 documents in collaboration with SMEs (material scientists, engineers, analytical chemists, and microbiologists).
- Reviews GLP reports prior to EPA submission.
- Works closely with clinical development teams, including clinical scientists, clinical affairs, regulatory affairs, biostatistics, physicians, and medical affairs, to ensure alignment and accuracy of clinical documents.
- Actively facilitates internal reviewer comment reconciliation and assesses agency responses.
- Writes, edits, and reviews scientific documents including, but not limited to analytical, microbiological, and packaging methods; method development summaries; method verification, validation, and transfer protocols and reports; standard operating procedures and work instructions; customer-facing technical briefs; claims reports; and/or specifications.
- Reviews scientific documents for accuracy, formatting, consistency, and compliance with scientific principles, regulatory guidelines, company standards, and industry best practices.
- Provides technical writing expertise, best practices training, and support to project teams, contributing to strategic planning and decision-making.
- Develops templates, guidelines, and standardizes writing, formatting, use of statistics, and figures department wide.
- Stays current with industry trends, guidelines, and best practices, and shares knowledge with the team.
Requirements:
- Advanced Degree with 3+ years of relevant regulatory writing experience, BS Degree with 7+ years of relevant technical writing experience
- CMC writing/authoring experience for small molecules or devices.
- PhD in Chemistry Preferred, or a combination of scientific BS/MS degree with equivalent industry experience
- Strong understanding of drug development, drug substance and drug product manufacturing, regulations (CFR, FDA, EMA, and ICH guidelines), scientific principles, and GCP/GLP/GMP guidelines.
- In-depth understanding of chemistry in the product development pipeline (synthesis/manufacturing process, impurities, analytical procedures, reference standards, stability studies).
- Expert knowledge of word processing, spreadsheets, table and graph generation, and use of applicable computer software
- Good working knowledge of scientific terminology, medical, pharmaceutical, and research concepts.
- Working knowledge of analytical and/or microbiological laboratory procedures.
- Knowledge of eCTD formatting and EDMS systems preferred.
- Experience with regulatory submissions (NDA/ANDA/IND) strongly preferred.
#m3
Ref: #558-Scientific
Job Tags
Full time,