Job description

Senior Medical Regulatory Writer

Conshohocken, Pennsylvania, United States

SENIOR MEDICAL REGULATORY WRITER

Join a pioneering biotech with a collegial atmosphere and a passion for harnessing every individual’s unique set of skills in our fight against disease.

At Immunocore, we have a vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. In January 2022, in the U.S., we launched the world’s first T-cell receptor therapy, built on a novel technology designed to overcome the limitations of our natural immune systems.

Joining us at the most exciting time in our history, you will be part of a team that values trust and innovation, and that cherishes different ways of thinking.

This position is located in Conshohocken, PA or Rockville, MD.

 

The Role:

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.  This Senior 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.

Supervisory Responsibility:

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 benefits, beginning your first day of employment
  • Vision benefits
  • 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.   

Applicants have rights under Federal Employment Laws:

Family and Medical Leave Act

Equal Employment Opportunity Commission

Employee Polygraph Protection Act

Uniformed Services Employment and Reemployment Rights Act (USERRA)

Right to work

EEO is the Law Supplement

Pay Transparency

 

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