At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder’s world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.
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.
Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company’s facilities and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for medical or religious reasons, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.”
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.