The Principal Medical Writer functions as a technical leader with good project management skills and customer-focused leadership and provided functional oversight for a smaller less complex program or programs. You will prepare clinical regulatory documents, including clinical summaries and clinical trial applications (INDs/CTAs) working in close collaboration with clinical teams to ensure timely completion of high-quality documents.
Through analysis of clinical data, you will independently prepares strategic program level documents such as clinical overviews, briefing packages and responses for regulatory agencies. You may also provide direction to junior medical writers on submission teams.
You will work in collaboration with the TA Lead to appropriately adapt TA area messaging and strategy for a program and are responsible for ensuring consistency of strategy and messaging through all documents for a program.
You are someone who possesses proficient knowledge of global requirements related to all aspects of clinical regulatory documentation to support their program(s) and acts as a medical writing subject matter expert to other departments.
What You’ll Do
- Provide Medical Writing leadership and authoring expertise for a smaller less complex program(s).
- Acts as a medical writing subject matter expert and works with the clinical team to deliver on medical writing program goals and document needs within the program.
- Manage medical writing deliverables for program(s) within their responsibility.
- Provide guidance to and oversight of internal and external writers on prioritization, content and timeline development, and process management.
- Contributes to overall department strategies and initiatives.
- Incorporates process improvements and changes that align with Department needs.
- Support the development of training programs and processes to help medical writing staff learn and develop program-specific knowledge.
- Contributes to a culture of customer focus and continual process improvement.
Who You Are
In addition to having excellent written and communication skills, you successfully worked in a matrix environment where you collaborated with other clinical teams.
You have excellent organizational abilities and function well on cross-functional teams. You are highly proficient and experienced with most clinical document types. You have a strong understanding of internal and external guidelines and regulations related to document preparation and program support.
- A Bachelor’s Degree in Life Sciences or health discipline required; Advanced degree preferred.
- 7 years’ experience in the biopharmaceutical industry; advanced degree/academic research or other transferrable skills may be considered in lieu of industry experience
- 5 years of medical writing experience.
- Therapeutic area knowledge and expertise on requirements for clinical / regulatory documents.
Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.