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Senior Director – ExploR&D Regulatory Writing and Capabilities
Eli Lilly and Company. Lead the regulatory and medical writing function within ExploR&D .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory and medical writing, with a strong focus on developing and managing clinical and regulatory documents. Proven ability to lead cross-functional teams, implement automation tools, and maintain compliance with regulatory guidelines.
Highest-signal resume keywords
Regulatory WritingClinical Trial DocumentationProject ManagementLeadership in Document DevelopmentAutomation Tools Implementation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsClinical DevelopmentPharmacologyToxicologyGCP RegulationsGLP RegulationsDocument Management SystemsClinical Study ReportsInvestigator’s BrochuresTarget Product Profiles
Soft Skills
Critical ThinkingStrategy DevelopmentDecision-MakingInterpersonal SkillsFlexibility
Tools & Technologies
AI Authoring ToolsAutomation ToolsDocument Management SystemsWord Processing SoftwarePresentation Software
Certifications & Qualifications
Advanced Graduate Degree (PharmD, PhD, MD)
Industry Keywords
Pharmaceutical IndustryPreclinical DevelopmentRegulatory GuidelinesBiotech PartnershipsCross-Functional Teams
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the regulatory and medical writing function within ExploR&D
- Oversee preparation and delivery of clinical and regulatory documents
- Develop IT tools supporting document-writing needs for ExploR&D and partners
- Provide strategic, tactical, technical, and operational direction across the ExploR&D portfolio
- Lead writing deliverables and strategies
- Collaborate with internal and external multidisciplinary stakeholders to produce regulatory and scientific documents
- Coordinate content across complex documents to ensure accuracy, compliance, and clarity
- Prepare and manage protocols, investigator’s brochures, clinical study reports, briefing documents, regulatory responses, Target Product Profiles, regulatory strategy documents, Integrated Development Plans, IND/CTA documents, abstracts, posters, manuscripts, and presentations
- Lead cross-functional teams and ensure timely writing deliverables
- Manage workload and escalate resource capacity issues
- Plan, write, edit, review, strategically coordinate, quality-review, and finalize documents
- Provide expertise on databases and document management systems
- Represent ExploR&D in assigned projects and interact with biotech partners
- Build and manage biotech partner and vendor relationships
- Advise on medical writing activities and asset development
- Identify and assess collaboration opportunities
- Maintain regulatory and publication guideline knowledge and share best practices
- Build AI writing capabilities and implement systems, automation tools, AI authoring tools, and document management systems
- Allocate medical writing resources and implement document standards, workflows, priorities, SOPs, and templates
- Coach, mentor, and train staff and cross-functional colleagues
- Recruit, develop, and retain medical writing staff if assigned
- Champion quality, safety, inclusion, innovation, and judgment-based decision-making
Requirements
What you’ll need- Advanced graduate degree (PharmD, PhD, MD) in a health-related or scientific field
- At least 7 years’ experience in the pharmaceutical industry in two or more of: preclinical development (PK/PD, pharmacology, toxicology), clinical development, CMC, regulatory affairs, regulatory writing
- Mastery of written English with at least 3 years’ experience writing regulatory, clinical trial documents, and/or scientific publications
- Experience in clinical trial process and/or regulatory activities
- Deep understanding of investigational product requirements, especially GCP and GLP regulations
- Demonstrated leadership in managing document development for various document types/indications
- Experience managing external partnerships/vendor relationships
- Critical thinking, strategy development, and decision-making skills
- Ability to influence strategies and deliver results in complex or ambiguous environments
- Project management and time management skills
- Strong leadership and team management skills
- Strong interpersonal skills and flexibility across varying environments and customer groups
- High-level end-user computer skills, including word processing, tables and graphics, spreadsheets, presentations, and templates
- Experience using, developing, or implementing automation tools and software solutions, including AI-driven tools
- Ability to work well across cultures and time zones
- Experience as a direct supervisor or leading cross-functional teams preferred
- Willingness/ability to travel up to 10% US and/or OUS
- Relocation is not provided
- A writing exercise may be required; writing samples may be requested
Benefits
Comp & perks- Flexible hybrid working options
- Healthcare benefits
- Pension plan
- Life assurance and life insurance and death benefits
- Subsidised canteen
- Onsite gym and fitness benefits
- Travel subsidies
- On-site parking
- Inhouse People Development services
- Educational Assistance
- Wellbeing initiatives
- Employee assistance program
- Employee clubs and activities
- Vacation benefits
- Certain time off and leave of absence benefits
- Company bonus eligibility depending on company and individual performance
- Quarterly travel to Indianapolis for remote US employees
- Flexible benefits (if applicable)