Senior Medical Regulatory Writer
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
This position is located in Rockville, MD or Conshohocken, PA.
The Senior Medical Regulatory Writer will be accountable for the medical, and scientific regulatory writing to support submissions from first in human studies through product registration. The Senior Medical Regulatory Writer will report to the Executive Director Regulatory Affairs and will interact with the regulatory, preclinical, clinical, translational medicine, PK/PD, and medical affairs groups working across functions to provide writing support of documents.
This Senior Medical Regulatory Writer will not only perform required writing within their scope and abilities but will also coordinate all aspects of medical writing for the current pipeline in collaboration with each functional group to ensure consistency of messaging. The Medical/Regulatory Writer will assist and provide necessary support to the teams in the creation of effective internal and external communications and documents for submission to health authorities. ThisSenior Medical Regulatory Writer will coordinate the activities of all external (contract) writers contributing to each project.
The ideal candidate will have a scientific background or degree, excellent leadership skills, have experience gained from working in the pharmaceutical industry (preferably with biologics), experience in the preparation of the necessary and essential documents to support regulatory fillings from first-in-human through marketing applications. This role will also require someone who can work within a highly innovative, agile, and entrepreneurial environment. The candidate will be able to provide input into the messaging strategy through effective collaboration and be able to deliver and work well under pressure to achieve timelines and ensure compliance with regulatory requirements.
This position will oversee and coordinate the activities of external (contract) writers, but otherwise has no direct supervisory responsibilities of Immunocore personnel.
EDUCATION & QUALIFICATIONS
BS with 2-5 years’ experience in medical/regulatory writing. Advanced degree M.S., PharmD, Ph.D., or M.D. with 1-3 years’ experience.
Limited overnight travel is expected for this position. There may be occasional local day travel between US offices.
Lead with Science and Discover What is Within:
- We value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Medical and vision benefits, beginning your first day of employment
- Fully paid Dental Insurance
- 20 days’ vacation plus holidays
- Fully paid Life Insurance and Disability
- 401(k) with Company Match
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.
Immunocore is an E-Verify employer.