Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.
The Director, Medical Writing, will be responsible for development and oversight of key clinical/regulatory documents ensuring clinical data is presented objectively in a clear, concise format in compliance with ICH guidelines and local regulatory requirements. Partner with Study Conduct Teams, Project Teams, and other functional leads to develop document strategy and support consistent documents/messaging within and across programs. Will support development of Medical Writing's roles and responsibilities in alignment with the company's needs.
- Manage or oversee multiple writing projects to promote company, department, and project team goals with respect to project scope, messaging, timelines, other activity planning, and budgeting/resourcing.
- Serve as lead writer on key documents including Investigator Brochures, Protocols, Clinical Study Reports and BLA clinical summary documents
- Provide writing strategy for product development with the vision to identify immediate and future document writing needs.
- Ensure efficient preparation and completion of high-quality, accurate, concise, and ICH-compliant medical writing deliverables.
- Partner with functional and other cross-functional representatives to develop or improve document planning/writing/QC standards, SOPs, style guide and processes as well as to identify potential areas where Medical Writing may expand its services.
- Organize and guide functional and cross-functional document planning, strategy, adjudication, or other team meetings.
- Chair Protocol Development and Approval Committees.
- Point of contact for all Medical Writing needs and related topics.
- Provide development opportunities for internal staff with regard to writing documents.
- Manage medical writing team (contract, vendor or full-time).
- Oversee medical writing vendor performance and activity with regard to medical writing and QC in accordance with Good Clinical Practice (GCP), ICH guidelines and federal regulations and other associated documents.
- Participate in Clinical Operations and cross functional initiatives such as process improvements and SOP development.
- Work with R&D Supplier Governance to develop request for proposal, evaluate, provide input into selection, and review bids for medical writing vendor(s).
- Develop and maintain/evaluate key performance indicators /metrics for medical writing and QC
- Provide support in the identification of training gaps, may support development of training materials to meet the gap and provide training as required to improve core competency and skill set for all staff contributing authoring or contributing to clinical and regulatory documents.
Qualifications & Experience
- Preferred Bachelor’s Degree in Science or Medical related field with 10+ years industry experience, Master’s Degree with 8+ years industry experience, or PhD with 7+ years industry experience.
- Experience with most of the more common regulatory documents such as CSRs, IBs, protocols, and clinical modules. Advantageous to have experience with a broader range of regulatory or process documents, such as plain language summaries, Advisory Committee Meeting support, Briefing Documents, subject safety narratives, SOPs, and templates.
- Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs.
- Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities.
- Preferable to have a solid technology background to support electronic/automated initiatives that result in more efficient and higher quality writing.
- At least 8 years of experience as a regulatory medical writer in biotechnology or equivalent, with 2-3 years of senior manager level experience or equivalent.
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.