Senior Manager, Medical​/Regulatory Writer

Location: Northern

## Job Details:
Senior Manager, Medical/Regulatory Writer Full details of the job.|  |  || --- | --- ||  |  ||  |  || --- | --- ||  | Senior Manager, Medical/Regulatory Writer ||  | VN831 ||  | Full Time ||  | Gaithersburg, MD, Radnor, PA, Remote, US ||  | Regulatory Affairs ||  | 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…