Experienced Medical Writer, Pharma (Clinical/Regulatory) - Top $$/Direct or Contract
Our client, an RTP-based pharmaceutical company in high–growth mode, is actively recruiting for a very sharp and versatile medical writer for key position on its Medical Affairs team. Position involves substantial original writing as well as the coordination/review/editing of the writing performed by vendors/contractors. Seek quality candidate who enjoys and excels at both.
This position is open due to growth. Company has both marketed products and a rich and growing pipeline. Seek skilled and knowledgeable candidate who effectively partners with the R&D teams to lead the research, authoring, editing, formatting and quality review of documents basic to drug development, detailed further below.
Key things to note:
- Company is open to either Direct Hire or Contractor candidates. Company will pay industry-leading wage to attract and retain a star. It is an office-based role with flexibility to work from home 2 days a week.
- This Medical Writer will support both marketed products (Safety-related documents (e.g. DSURs)) and products in development (Clinical, Regulatory, etc.). Seek candidate with broad exposure and skill.
- This is a highly collaborative role involving coordinating the input of both colleagues and vendors. Right candidate will complement polished and compliant Medical Writing skills with practiced and effective Project Management skills.
Specific duties will include:
- Author or coordinate the authoring of the following Clinical Documents:
- Study Protocols
- Clinical Study Reports
- Clinical Study Summaries (for posting to study registries)
- Author or coordinate the authoring of the following Regulatory Documents:
- Common Technical Document (CTD) clinical and nonclinical sections for IND, NDA and MAA documents
- Briefing Documents for Regulatory Interactions, e.g., FDA Meetings, EMA Scientific Advice
- Responses to Regulatory Agency questions
- Investigator Brochure
- Orphan Drug Designation Requests
- Manuscripts and posters, including support for primary author, writing or coordinating first drafts, managing internal and external reviews and journal submission
- Author or coordinate the authoring of the following multidisciplinary documents:
- Manage external medical writing resources
- Organize Framework Meetings prior to the initiation of key clinical or regulatory documents to ensure alignment on essential insights and scope
- Coordinate the review and quality check of all documents
- Work with Clinical Development, Biostatistics, Safety, Regulatory Affairs, and Project Management to ensure document preparation timelines are consistent with Program goals
Seek a skilled and experienced medical writer who can bring significant expertise and insight.
Ideal candidate will offer a related degree and 5+ years producing high-quality documents in a pharma/CRO setting. Extensive knowledge of document formats/techniques, expert attention to detail and reliable conformance to industry/company standards are presumed and essential. Familiarity with clinical protocol and CSR writing, documents for submissions in electronic Common Technical Document (e-CTD) format, and detailed and experienced-based understanding of applicable regulations, and the CTD structure all assumed and important.
In addition, we seek a Medical Writer with demonstrated ability to build collaborative relationships with colleagues and partners. This is a point-person role. Seek skilled project leader who can thrive.
This is an important role and an immediate need. Please forward Word resume for prompt reply. Local candidates only.