Company DescriptionJob Description
About This Role:
As a Principal Medical Writer, you will function as a technical leader with good project management skills and customer-focused leadership. You will provide functional oversight for a smaller less complex program(s), or may function as an individual contributor on a large, more complex program. You will prepare or oversee the preparation of clinical regulatory documents working in close collaboration with clinical teams to ensure timely completion of high-quality documents. Documents may include protocols, investigator's brochures, clinical study reports, components of INDs/CTAs, as well as 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 be 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 your program(s) and act 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) or may function as an individual contributor on a large, more complex program.
Acts as a Medical Writing subject matter expert and work 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 your responsibility.
Provide guidance to and oversight of internal and external writers on prioritization, content and timeline development, and process management.
Contribute 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.
Contribute to a culture of customer focus and continual process improvement.
Who You Are:
In addition to having excellent written and oral communication skills, you successfully work in a matrix environment where you collaborate 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 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; neuroscience experience preferred.
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.