The Director/Senior Director of Medical Writing is responsible for leading a centralized technical writing organization, while continuing to assess the writing needs across the R&D organization to support clinical regulatory submissions.
The Director/Senior Director, Medical Writing must ensure that quality systems and processes are in place to support the author, review, and approval of documents and ensure appropriate templates are in place for documents such as, but not limited to, Clinical Study Reports, Protocols and Investigator Brochures and other documents necessary for clinical regulatory submissions. This position must facilitate the planning and coordination of writing activities across R&D, including clinical development, clinical operations, regulatory, pharmacovigilance, pharmacology, biostatistics and CMC, for the completion of quality, submission ready documents in support of Boston Biomedical, Inc regulatory submissions.
The Director/Sr. Director, Medical Writing is accountable for coordination of all aspects of technical writing, including vendor selection and management, resource planning and execution across all areas requiring writing support. The Director/Sr. Director, Medical Writing provides leadership, guidance, medical writing expertise and direction to both R&D staff as well as vendors and independent consultants responsible for the completion of submission ready documents.
Reporting Relationship: Sr. Director, PV Operations and Compliance
- Leads, directs, and mentors the medical writing team
- Accountable for the identification, selection and oversight of qualified vendor(s) or consultants as required to prepare, write, edit, and review clinical and regulatory documents in collaboration with the clinical development teams.
- Ensure development and maintenance of SOPs related to the development of clinical regulatory documents.
- Establish writing standards that include document templates and style guides compliant with regulatory agencies and writing standards in collaboration with clinical development teams.
- Establish medical writing timelines and forecast writing needs and ensure appropriate resources.
- Set standards for process of document review, completion and approval, ensure adherence to regulatory requirements, standards, and consistent with America Medical Writing Standards or other writing standards, where applicable.
- Establish standard quality control (QC) system of review for clinical regulatory documents and oversees management of the process.
- Ensure proper training of staff and/or vendor on medical writing templates, SOPs, and processes including use of electronic document system within the department and across departments.
- Perform other duties as assigned.
- Bachelor’s degree in a life sciences discipline required and a minimum of 15 years biopharmaceutical industry experience. Masters/PhD degree in a life sciences discipline preferred.
- Must have at least 10 years in technical writing with 5 years of experience in managing staff of medical writers and/or vendors in preparation of technical documents (e.g., CMC, nonclinical, clinical, regulatory, etc.) including publishing and submissions.
- Prior IND/NDA/BLA submission experience, including eCTD, is required.
- Strong knowledge of FDA/ICH guidelines and GCP.
- Strong written and verbal communication skills.
- Expert abilities in Microsoft Word, Excel, and PowerPoint;
- Experience with Adobe Acrobat and Medical writing software preferred.
- Experience in coordination and prioritization of multiple projects in a fast-paced environment.
- Must have proven ability to understand and interpret clinical trial output; summarize complex results and present them in a clear, concise, and scientifically accurate manner to various end users.
- Background in oncology drug development is preferred.
- Fluent in English (oral and written)
Job Location: Cambridge, MA
Please send resumes to firstname.lastname@example.org