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Associate Director, Medical Writing – Experimental Medicine
Boehringer Ingelheim. Assume the role of project medical writer across early clinical development .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory medical writing and scientific communications, with a strong understanding of clinical development processes and international writing standards. Capable of managing projects across regions, ensuring quality and timeliness of clinical documents while effectively communicating complex information.
Highest-signal resume keywords
Regulatory Writing ExpertiseProject Medical Writing ExperienceAdvanced Degree (PharmD, PhD, MD)Understanding of Clinical Development ProcessExcellent Written and Verbal English Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory WritingClinical Trial ReportsProtocolsInvestigator’s BrochuresDocument Strategy DevelopmentClinical Data InterpretationProject ManagementScientific CommunicationsMedical Concepts UnderstandingStatistical Analysis
Soft Skills
Interpersonal SkillsCommunication SkillsPresentation SkillsDiplomacyCultural Sensitivity
Tools & Technologies
Word Processing SoftwarePresentation Software
Industry Keywords
Healthcare IndustryClinical DevelopmentRegulatory GuidelinesSOP ComplianceGlobal Marketing Approvals
About the role
Key responsibilities & impact- Assume the role of project medical writer across early clinical development
- Coordinate with other functions, plan timelines, and devise and execute document strategy
- Write key clinical documents for assigned projects
- Oversee regulatory documents written by internal or external medical writers
- Contribute to scientific and regulatory discussions within project teams
- Demonstrate expertise in the assigned therapeutic area
- Prepare clinical documents at project and study level for phase transitions and regulatory approval
- Plan document and submission timelines and develop document strategies
- Resolve and integrate review comments and oversee timelines
- Coordinate cross-functionally to ensure timely and successful document finalization
- Ensure quality and timeliness of documents assigned to external providers through oversight, training, and cost control
- Implement medical writing standards in governance of external providers
- Contribute to international cross-functional working groups and global SOP development
- Represent the Experimental Medicine Medical Writing function in cross-functional working groups
- Interact with leadership, influence strategic objectives, and ensure implementation
- Develop and share knowledge in major indications and key document types
- Mentor and train other medical writers
- Provide expert advice to other functions
- Apply global, local, and regional regulatory guidelines to clinical documents
- Comply with applicable SOPs and company policies
Requirements
What you’ll need- Advanced degree (e.g., PharmD, PhD, MD) from an accredited institution is preferred with at least four (4) years of relevant experience in regulatory medical writing/scientific communications in the healthcare industry
- Master’s degree from an accredited institution with a minimum of six (6) years of experience in scientific communications and/or regulatory medical writing will be considered
- Bachelor’s degree from an accredited institution with a minimum of eight (8) years of experience in scientific communications and/or regulatory medical writing will be considered
- Experience as a project medical writer
- Expertise in regulatory writing, including protocols, clinical trial reports of early clinical phases, investigator’s brochures, and other clinical documents
- Understanding of international writing standards and conventions
- Understanding of business impact of timelines for key clinical documents
- Understanding of medical concepts, statistics, pharmacokinetics and pharmacodynamics
- Understanding of the clinical development process and relevant global and local regulatory guidelines
- Knowledge of requirements for regional and local marketing approvals
- Ability to independently and effectively communicate complex clinical information in writing
- Ability to comprehend and interpret clinical data
- Ability to manage projects across regions and in matrix environments, including time management and oversight of external providers
- Ability to manage parallel tasks and variable workload
- Ability to communicate effectively in international cross-functional teams
- Ability to manage conflicting interests
- Ability to contribute to process improvements
- Proficiency in word processing and presentation software
- Excellent written and verbal English skills
- Scientific and analytical thinking
- Strong interpersonal and social skills
- Presentation skills
- Diplomacy
- Cultural sensitivity
- Experience working globally on clinical documents for submission to health authorities in major regions (US, EU, Asia) and knowledge in the assigned therapeutic area (desired)
- Expertise in the assigned therapeutic area and its clinical standards, including new medical or statistical approaches (desired)
Benefits
Comp & perks- Role-specific discretionary bonus may be available
- Relocation assistance may be available
- Medical coverage
- Dental coverage
- Vision coverage
- Retirement savings opportunities
- Paid time off
- Paid holidays
- Disability insurance benefits
- Life insurance benefits
- Other company-sponsored benefits
- International collaboration opportunities
- Meaningful work, mobility, networking and work-life balance support