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Director, Global Medical Writing
Deciphera Pharmaceuticals. Serve as lead writer across clinical programs and submissions in the clinical pipeline .
Posted 10/28/2026full-timeRemote • Massachusetts • United StatesLead💰 $175,000 - $215,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in medical writing for clinical and regulatory documents, including NDA, NDS, MAA, and IND submissions. Proven ability to lead cross-functional teams and manage multiple projects while maintaining high-quality standards and timelines.
Highest-signal resume keywords
Medical Writing ExperienceRegulatory Submission ExpertiseClinical Document ManagementAdvanced Degree (MS or Ph.D.)Attention to Detail
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Study ProtocolsInvestigator’s BrochuresClinical Study ReportsRegulatory Response DocumentsClinical Trial DisclosureECTD Starting Point TemplatesStatistical Analysis PlansDocument StrategiesContent Strategy DevelopmentMedical Literature Searches
Soft Skills
Excellent Verbal CommunicationExcellent Written CommunicationStrong Organizational SkillsPrioritization SkillsMentoring
Tools & Technologies
Smart SheetMS OfficeVeeva VaultPlease ReviewSharePoint
Industry Keywords
OncologyImmunologyNeurologyICH RegionsNDANDSMAAIND
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Serve as lead writer across clinical programs and submissions in the clinical pipeline
- Independently write and manage clinical study-related documents, including clinical study protocols, master protocols, Investigator’s brochures, and clinical study reports
- Lead cross-functional teams developing regulatory submission documents, regulatory response documents, and IND/CTA or global regulatory submission documents
- Lead Medical Writing for one or more clinical programs, including planning, developing, and implementing content strategy
- Represent Medical Writing on cross-functional clinical, regulatory, and submission teams
- Participate in NDA/MAA/IND submission planning and documentation
- Author and manage clinical documents and assigned tasks within established timelines and quality standards
- Drive document strategies and messaging with project-team subject matter experts
- Maintain current knowledge of medical writing developments and related technologies
- Incorporate process improvements aligned with R&D needs
- Plan and coordinate work with in-house Medical Writers and outside CROs
- Perform medical literature searches
- Participate in company-wide initiatives, including protocol template working groups and IB standardization
- Review medical writing deliverables, statistical analysis plans, tables, figures, and listings as needed
- Manage and mentor 1–2 direct reports, with future oversight of writing across a therapeutic area
- Report to the Senior Director, Global Medical Writing
Requirements
What you’ll need- Advanced degree (MS or Ph.D.) in a relevant scientific field; Ph.D. preferred
- Minimum of 8–10 years of medical writing experience
- Expert knowledge and experience preparing high-quality clinical and regulatory documents
- Knowledge of clinical trial disclosure
- Experience authoring regulatory and clinical documents for global submissions, including NDA, NDS, MAA, and IND submissions across ICH regions
- Active contribution to planning and preparation of summary documents
- Excellent verbal and written communication skills
- Attention to detail regarding consistency, grammar, syntax, and accuracy
- Strong organizational and prioritization skills for managing multiple concurrent documents
- Proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software, MS Office (Teams, Outlook, Word, Excel, PowerPoint, SharePoint), Veeva Vault, and Please Review
- Oncology, immunology, and/or neurology experience highly preferred
Benefits
Comp & perks- Annual performance bonus
- Long-term incentive plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with company match
- Generous parental leave
- Family planning benefits
- Opportunities for personal and professional growth