Penfield Search Partners
Contact: Linda Aronova 646.882.9021 firstname.lastname@example.org
- Writes and/or edits clinical regulatory documents (all document types).
- Prepares regulatory documents (eg, Module 2 and other clinical CTD documents, briefing and response documents [requests for information, deficiency letters], pediatric clinical development plans). Ensures documents are accurate, complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
- Guides clinical (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
- Provides leadership/strategy at the therapeutic area level for documents and complex submissions
- Contributes at the program, submission team, and therapeutic area level.
- Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
- Ensures quality assurance of own documents – implementation of comments received from CQA.
- Works independently and collaboratively in a cross-functional global team
- Communicates information clearly and concisely
- Manages preparation of clinical documents for submissions
- Participates in CDTs and study team meetings, provides alignment with documents within overall program strategy
- Lead CRMs and sets up document reviews as needed (eg, if MW doesnt have access to company systems or have a company systems superuser)
- Prepares or reviews and maintains document timelines
- Uses various tools, business systems, and repositories
- Provides oversight of assigned internal and external medical writers to deliver high-quality documents on time, consistent with internal standards, and within budget
- Oversees/mentors for all document types
- Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities
- Responsible for tracking/proving metrics and established key performance indicators, contributing to the budget process, and handling invoices
- Identifies processes that require improvement, and demonstrates big picture perspective, leveraging experience, to recommend strategies and solutions
- Contributes to manuscript preparation as needed
- Ph.D. or a Master’s degree in Life Sciences (or other related field), both with a minimum of 10 years of experience.
- Minimum of 7 years of writing experience of clinical regulatory documents in the Biopharmaceutical/CRO industry.
- Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines, and key statistical concepts.
- Proficient in MS Word and experience with document templates
- Experience with an electronic document management system
- Familiarity with the principles of clinical research and drug development, including clinical trial design, operations, and results analysis
- Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
- Experience managing direct and indirect reports, including medical writing contractors