Core Recruiter
Stripe
Salary
💰 $188,000 - $259,000 per year
Job Level
Lead
About the role
- Write and/or manage complex marketed and development programs at the portfolio level based on Therapeutic Area, disease state, and/or phase of development
- Provide direct supervision for Medical Writing program leads and mentor junior writers
- Respond to Medical Writing issues with internal cross-functional teams and external development partners
- Contribute to long-term growth strategy of the department and ensure SOPs are followed across projects
- Synchronize prioritization of projects and represent Medical Writing in meetings with governance committees, regulatory agencies, and external development partners
- Perform outreach within pharmaceutical/biotech industry to maintain knowledge of evolving industry standards and establish best practices
- Prepare clinical and regulatory documents and packages: protocols and amendments, CSRs, IBs, INDs/CTAs, submissions
- Lead planning, development, and delivery of documents according to ICH guidelines, company SOPs, templates, and regulatory requirements
- Support development and maintenance of SOPs and templates for document development
- Critically analyze and synthesize complex scientific information to ensure scientific accuracy and consistency of documents
- Develop and integrate messaging and medical writing strategy to ensure consistency through documents in a therapeutic area
- Collaborate with cross-functional SMEs including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations
- Participate in regulatory submission planning, timelines, and document development
- Manage and/or provide oversight of in-house and/or contractor/vendor medical writers, ensuring high-quality deliverables
- Review statistical analysis plans and clinical data reports incorporated in data-related documents and provide strategic input to TFL outputs
- Lead departmental initiatives as necessary
Requirements
- Minimum of BSc + 12 years’ experience in Medical Writing, or Advanced degree + 7 years’ experience in Medical Writing (pharmaceutical, biotechnology, or CRO setting)
- Experience with global regulatory submissions (e.g. BLA/NDA, MAA)
- Familiarity with eCTD format and relationships between documents
- Familiarity with ICH, FDA, and EMA guidelines and regulations, as well as public disclosure requirements for documents
- Proven experience authoring documents and leading teams through the authoring process
- Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment
- SME in MS Word, and proficiency in document management systems (Veeva, SharePoint)
- Experience in managing and/or mentoring other medical writers or external vendors preferred
- Exceptional written and communication skills
- Experience working in a matrix environment and collaborating with clinical teams
- Expert knowledge of global requirements for clinical regulatory documentation across Phases 1-4
