EPM Scientific ยท 2 days ago
SR Manager/Associate Director Med Writing
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$150K/yr - $185K/yr
6+ years expEPM Scientific is seeking a Senior Manager/Associate Director in Medical Writing. The role involves leading the creation of regulatory documents and collaborating with cross-functional teams to ensure compliance and timely delivery for major submissions.
BiotechnologyRecruiting
Hiring Manager
Colin Schifferman
Responsibilities
Lead the creation of key regulatory documents, including clinical overviews, summaries, and study-specific content for major submissions
Draft and update clinical study reports, investigator brochures, and standard operating procedures
Contribute to protocols, amendments, statistical analysis outputs, briefing materials, and responses to regulatory inquiries
Define document strategies, develop outlines, and establish timelines for deliverables
Manage version control and coordinate review cycles to ensure audit-ready completion
Partner with clinical, statistical, regulatory, safety, and technical teams to ensure accuracy, consistency, and timely delivery of documents
Translate complex clinical and statistical data into clear, compliant narratives aligned with submission objectives
Ensure adherence to global regulatory standards, internal guidelines, and style conventions
Support template enhancements and process optimization initiatives
Drive quality checks, maintain traceability to source data, and reconcile comments to ensure readiness for regulatory review
Monitor timelines and risks, escalate issues proactively, and implement solutions to maintain delivery commitments
Qualification
Required
Minimum 6 years in pharma, biotech, or CRO settings with a strong focus on oncology
Bachelor's degree in a life science discipline
Proven authorship of BLA clinical modules (2.5 Clinical Overview, 2.7 Clinical Summary, and relevant Module 5 content)
Experience drafting protocols and amendments, SAP-aligned tables and appendices, briefing packages, and responses to health authority queries
Deep understanding of ICH, FDA, and EMA guidelines, oncology trial design, endpoints, and evolving regulatory requirements
Ability to interpret complex clinical and statistical data and translate it into clear, compliant regulatory narratives
Exceptional writing and editing skills combined with strong project management; able to work independently and collaboratively in fast-paced, deadline-driven environments
Demonstrated ability to lead document strategy, develop outlines and timelines, manage version control, and deliver audit-ready documents
Hands-on experience ensuring quality control, data traceability, and comment reconciliation for major submissions
Active involvement in BLA/NDA/MAA filings through submission and review, including supporting responses to agency questions
Skilled in document and workflow systems such as Veeva, eTMF, CTMS, and electronic review tools
Proven success partnering with Clinical, Biostatistics, Regulatory, Safety, and CMC teams; adept at milestone tracking and risk management
Ability to work core Eastern or Central U.S. hours in a remote U.S.-based role
Preferred
Advanced degree preferred
Company
EPM Scientific
EPM Scientific is proud to be a leading specialist recruitment agency for the life sciences industry.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
S
Sean P.
Senior Vice President Commercial - Field at EPM Scientific
Recent News
BioSpectrum Asia
2023-12-23
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