Director, Regulatory Writing
Boston - United States
Seeking highly experienced and motivated Regulatory Writing Leader to join a small group with a well-known and established global pharmaceutical organization in the Boston area. Searching for a Director to join a small group who comes with a diversified regulatory background since this role requires more than just writing. This role is reporting to the VP of Regulatory Affairs and will work closely with the Team Lead to develop regulatory documents and strategies. The Director, Regulatory Writing will oversee quality review for clinical and regulatory documents and oversee the preparation of clinical documentation in support of clinical development, trials, and filings.
- Responsible for leading, coordinating, compiling, and producing routine regulatory submissions/amendments, according to company, ICH, and health authority guidelines.
- Lead submission document writing strategies (IND, CTA, NDA, BLA, MAA), and clinical documents as well (Module 2.5, etc.).
- Generate complex clinical study-related documents, including protocols, protocol amendments, informed consent forms, Investigator Brochures, study manuals, and CSRs to support clinical development programs.
- Tracking all timelines on regulatory deliverables as well as providing project updates - this will include highlighting any risks that might impact the ability to achieve corporate goals.
- Program Management responsibilities in creating and negotiating timelines, budgets, risk analysis assessments, etc.
- Ensure that all regulatory submission documents are fully compliant with internal document standards.
- Work closely with the team and outside employees as well to ensure that all regulatory practices and strategies are fully executed, and all submissions are evaluated and reviewed thoroughly to ensure the following: completeness, well-organized, scientifically accurate, of high quality, in regulatory compliance, and presented in a manner that facilitates agency review.
- Lead roundtable and kick-off meetings with the team and cross-functions.
- Coordinate review and approval of oncologic clinical study-related documents
- Generate new templates and contribute to the maintenance of templates and standard text for clinical documents.
- Significantly contribute to discussions regarding document content, informed by a review of pertinent publications, guidance, and/or discussions with outside experts
- Provide document support as needed to Regulatory Affairs.
- Perform peer and quality control (QC) review of Medical Writing documents prepared by other writers.
- Mentor other medical writers, providing scientific and operational guidance and coaching in the design, planning, and execution of their assignments.
- Bachelor's degree in a Scientific discipline required (advanced degrees are highly preferred)
- 8 years of Medical Regulatory Writing experience with evidence of increasing responsibility/technical development.
- Knowledge of regulations relevant to medical writing within oncology.
- Prior hands-on leadership and management experience
- Must have Global & Regional regulatory writing experience for both US and EU.
If you meet the qualifications & interested in learning more, please contact Bria Gaber at firstname.lastname@example.org for more information.