MAIN PURPOSE OF JOB
The 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 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 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 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.
- 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. Authoring clinical trial publications including collaborating with data analysis and publications development, including working with external authors to align publications across the Company.
- Collaborating and driving the scientific narrative of the later stage pipeline in collaboration with medical affairs by reviewing and editing other key documents.
- 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.
- Overseeing and coordinating all external writers for assigned products 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 procedures and working practices commensurate with the requirements of a company.
- 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.
This position will oversee and coordinate the activities of external (contract) writers, but otherwise has no direct supervisory responsibilities of Immunocore personnel.
- Excellent writing and technical editing skills
- Communication proficiency
- Experience with at least one EDR and/or RIMs system (preferred but not required)
- Attention to detail
- Efficient time management
- Collaborative and able to work effectively in a matrixed work environment
- Personal effectiveness and credibility
- Judgement and flexibility
- Technical Capacity
- Stress management and composure
IMMUNOCORE VALUES – ALL STAFF
- We lead with science to benefit patients
- We are entrepreneurial
- We value diversity to drive innovation
- We respect each other and act with integrity
- We do the right thing
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Experience & knowledge
- 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 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 2-5 years’ experience in medical/regulatory writing. Advanced degree M.S., PharmD, Ph.D., or M.D. with 1-3 years’ experience.
Additional Eligibility Qualifications
None required for this position.
WORK AUTHORIZATION/SECURITY CLEARANCE (IF APPLICABLE)
Work authorization in the USA is required
Immunocore LLC provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand as necessary.
POSITION TYPE AND EXPECTED HOURS OF WORK / TRAVEL
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m.
Limited overnight travel is expected for this position. There may be occasional local day travel between US offices.
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.