Senior Medical Writer in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Medical Writer in United States.

This role sits at the heart of clinical development and regulatory documentation, where scientific rigor meets clear and compliant communication. You will be responsible for transforming complex clinical data into high-quality documents that support drug development, regulatory submissions, and global product approvals. Working within a leading rare disease research environment, you will collaborate closely with cross-functional teams including clinical, regulatory, biostatistics, and medical affairs. The position plays a critical role in ensuring accuracy, consistency, and regulatory compliance across all clinical study documentation. You will also contribute to process improvements, document strategy, and cross-functional alignment across development programs. This is a highly collaborative and detail-driven role with direct impact on advancing therapies for patients with rare and genetically defined conditions.

• Draft, edit, and finalize key clinical study documents including protocols, protocol amendments, informed consent forms, and clinical study reports.
• Prepare and review regulatory and aggregate safety documents such as investigator’s brochures, PBRERs, DSURs, and other safety or efficacy reports.
• Support preparation of regulatory submission materials including briefing books and eCTD Module 2 and Module 5 clinical summaries.
• Lead and manage document development processes, including timelines, cross-functional meetings, and review/comment adjudication workflows.
• Serve as a representative of Global Medical Writing in cross-functional study and development team meetings.
• Collaborate closely with clinical, regulatory, statistical, and scientific teams to ensure alignment and quality of deliverables.
• Provide peer review and editorial support for related study documentation, including statistical analysis plans and CRFs.
• Contribute to the development and refinement of internal standards, templates, and medical writing best practices.

• Bachelor’s or higher degree in a scientific or related field.
• Up to 6 years of experience in medical writing within the pharmaceutical industry, or 10+ years of scientific/medical writing experience.
• Strong experience drafting and editing clinical study protocols and clinical study reports.
• Familiarity with regulatory documentation such as INDs, NDAs, BLA submissions, PBRERs, DSURs, and related regulatory filings.
• Solid understanding of the drug development lifecycle, clinical study design, and clinical research methodology.
• Knowledge of regulatory frameworks and eCTD structure (Modules 2–5), including integrated summaries of safety and efficacy.
• Ability to interpret complex clinical data and translate it into clear, accurate, and compliant scientific writing.
• Strong project management skills with the ability to manage multiple priorities and lead cross-functional document development processes.
• Excellent written and verbal communication skills, with the ability to explain complex scientific concepts clearly.
• Proficiency in Microsoft Office tools and document management systems (e.g., SharePoint, Veeva, LiveLink).
• Preferred: certification or formal training in medical writing or scientific editing (e.g., AMWA or similar programs).

• Opportunity to work in a mission-driven organization focused on rare genetic diseases and life-changing therapies.
• Exposure to end-to-end clinical development, from research through regulatory submission and market approval.
• Collaborative, science-driven environment working with leading experts across clinical, regulatory, and research functions.
• Strong focus on professional development, certifications, and continuous learning in medical writing and regulatory science.
• Inclusive and equal opportunity workplace supporting diversity and accessibility.
• Opportunity to contribute directly to global regulatory submissions and impactful medical documentation.
• Structured processes and tools supporting high-quality documentation and efficient cross-functional collaboration.