Associate Director-Medical Writer
Eli Lilly and Company
August 25, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Job Responsibilities
- Lead the planning, authoring, and review of complex clinical and regulatory documents, including Clinical Protocols, Investigator’s Brochures (IBs), IMPDs, regulatory submission documents (IND/NDA/BLA modules), Clinical Study Reports (CSRs), and briefing documents.
- Manage multiple writing projects concurrently to ensure prompt delivery and quality.
- Collaborate with cross-functional teams (clinical development, regulatory affairs, biostatistics, medical affairs, nonclinical, legal) to gather information and ensure scientific accuracy and consistency.
- Interpret and synthesize complex scientific and clinical data into clear, concise written communications.
- Provide strategic input on document content and messaging aligned to project objectives and regulatory requirements.
- Mentor and provide guidance to junior medical writers.
- Maintain strong understanding of therapeutic areas, drug development processes, and regulatory guidelines (ICH, FDA, EMA).
- Develop and implement medical writing standards, templates, and guidelines.
- Represent medical writing at internal and external meetings.
Basic Qualifications
- Bachelor’s degree in a relevant scientific field required; Master’s or PhD preferred.
- Minimum 8 years of medical writing experience in pharma/biotech/CRO industry.
Additional Skills/Preferences
- Expertise authoring regulatory documents (CSRs, IBs, protocols, regulatory submissions).
- Strong understanding of drug development processes, clinical trial design, biostatistics, and regulatory requirements.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems.
- Experience leading or mentoring junior writers highly desirable.
- Lead the planning, authoring, and review of complex clinical and regulatory documents, including Clinical Protocols, Investigator’s Brochures (IBs), IMPDs, regulatory submission documents (IND/NDA/BLA modules), Clinical Study Reports (CSRs), and briefing documents.
- Manage multiple writing projects concurrently to ensure prompt delivery and quality.
- Collaborate with cross-functional teams (clinical development, regulatory affairs, biostatistics, medical affairs, nonclinical, legal) to gather information and ensure scientific accuracy and consistency.
- Interpret and synthesize complex scientific and clinical data into clear, concise written communications.
- Provide strategic input on document content and messaging aligned to project objectives and regulatory requirements.
- Mentor and provide guidance to junior medical writers.
- Maintain strong understanding of therapeutic areas, drug development processes, and regulatory guidelines (ICH, FDA, EMA).
- Develop and implement medical writing standards, templates, and guidelines.
- Represent medical writing at internal and external meetings.
Basic Qualifications
- Bachelor’s degree in a relevant scientific field required; Master’s or PhD preferred.
- Minimum 8 years of medical writing experience in pharma/biotech/CRO industry.
Additional Skills/Preferences
- Expertise authoring regulatory documents (CSRs, IBs, protocols, regulatory submissions).
- Strong understanding of drug development processes, clinical trial design, biostatistics, and regulatory requirements.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems.
- Experience leading or mentoring junior writers highly desirable.