You will oversee the direction, planning and execution of clinical and regulatory documents. This role is the internal subject matter expert, leading a team of medical writers in the development of clinical documents that will be referenced for regulatory approvals.
KEY ROLE AND RESPONSIBILITIES:
- Provide Medical Writing support for all assets from pre-IND to BLA.
- Act as a medical writing subject matter expert, working with clinical development and regulatory team to deliver on medical writing program goals.
- Managing and directly contributing as required to the development of a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, IND and BLA and other regulatory submissions documents.
- Managing and directly contributing as required to the development of publications/presentations of emerging clinical data for Congresses and/or other external stakeholders.
- Managing and directly contributing as required to the development of manuscripts summarizing the emerging clinical data.
- Managing and directly contributing as required to the planning and coordination of timelines to ensure timely completion of writing projects.
- Administer timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.
- Provide support for QC of complex clinical documents.
- Ensure that the key messages are aligned across protocols, publications, presentations and regulatory documents.
- Ensure that the Medical Writing department is fully resourced to manage the workload for multiple clinical and pre-IND assets.
- BA/BSc in scientific or medical discipline with a minimum of 15 years’ experience; or
- MBA or MSc with a minimum of 10 years’ experience
- 10+ years medical writing experience for a pharmaceutical or biotech is required.
- Extensive demonstrated experience in the writing of Protocols, Investigator Brochures, Briefing Documents, DSURs, and other Regulatory documents.
- Experience building a team and supervising medical writers (whether in an Agency, consultants and/or full-time employees).
- Additional experience directly contributing to and/or supervising the writing of congress presentations and manuscripts is preferred.
- Experience in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers.
KNOWLEDGE, SKILLS AND ABILITIES:
- Excellent written communication skills and attention to detail related to consistency, grammar, structure, and accuracy.
- Strong organizational/prioritization skills for the management of multiple concurrent projects.
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches.
- Strong project management and organizational skills.
- Willingness to work collaboratively with multifunctional teams and partners.
At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees.