Senior Manager, Medical/Regulatory Writer

Location: Gaithersburg United States

Job Description:

Vacancy Name

Senior Manager, Medical/Regulatory Writer

Vacancy No

VN831

Employment Type

Full Time

Location of role

Gaithersburg, MD, Radnor, PA, Remote, US

Department

Regulatory Affairs

Key Responsibilities

The Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. This role involves strategic planning and coordination across multiple functions to ensure consistency and quality in all regulatory documents. The Senior Manager, Medical/Regulatory Writer will report to the Director Medical Writing and will interact with regulatory, PV, preclinical, clinical, translational medicine, PK/PD, and medical affairs groups working across functions to provide writing support and contribute to regulatory messaging strategy in collaboration with cross-functional teams.

This Senior Manager, 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 assigned programs in the pipeline in collaboration with each functional group to ensure consistency of messaging. The Senior Manager, 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 Manager, 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.

KEY RESPONSIBILITIES

• Writing responsibilities across preclinical, clinical development, medical affairs, translational medicine, and regulatory affairs.
• Authoring clinical study protocols in collaboration with the clinical scientist/clinical project manager and study medical monitor
• Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
• Authoring clinical study reports (CSR) from individual clinical studies.
• Complying with internal and external processes and guidelines while managing the writing review process and resolving issues, errors, or inconsistencies with pertinent team members to ensure timely completion and quality of assigned documents.
• Managing and coordinating all external writers supporting assigned programs to ensure consistency of messaging and timely delivery of documents per project plans.
• Provide input for the development and writing of regulatory submission documents, ex. Briefing documents, IND/CTA supporting documents, labelling, and CTD/BLA/MAA documentation for eCTD compliant submissions.
• Contribute to the establishment and development of medical writing procedures and best practices.
• Responsible for maintaining archival files of regulatory documents that must have a controlled limited-access version maintained in a secure area.
• As assigned, perform quality control (QC) review of documents which are part of various regulatory submissions as per project requirements. Examples include to look for typographical, grammatical/spelling, formatting, flow and language and general clarity of text.

SUPERVISORY RESPONSIBILITY

This position has no direct supervisory responsibilities of Immunocore personnel but will oversee and coordinate the activities of external (contract) writers,

Experience & knowledge

Essential

• Track record in writing medical research documents, including protocols, clinical study reports, health authority briefing documents.
• Competent in use of MS Word, macros and templates to enable efficient writing, and the ability to efficiently use Adobe Acrobat to create bookmarked and hyperlinked submission-ready documents.
• Understanding of global regulatory requirements to be able to provide input into writing strategy and messaging.
• Experience in supporting global clinical studies and development programs as a writer.
• Ability to be agile to accommodate changing priorities
• Proven leadership, excellent communication and interpersonal skills.
• Exceptional attention to detail and highly organized.
• Interpersonal skills allowing for interactions with all participants in the writing of documents.
• Capable of maintaining logical processes for the inventory and tracking of documents within the eDMS/RIMS.

Preferred Experience & knowledge

• Experience with use of master and sub protocols, umbrella trials, and/or basket studies.
• Experience with short turnaround RFI responses to health authorities.
• Experience in use of at least one eDMS and/or RIMs system.
• Experience in use of at least one review and collaboration system for reviews of documents.

Education & qualifications

BS with 4-7 years' experience in medical/regulatory writing and 7-10 years' industry experience. Advanced degree M.S., PharmD, Ph.D., or M.D. with 3-5 years' experience.

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.

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