Associate Director, Medical Writing – Experimental Medicine

🕒 November 2

🇩🇪 Germany – Remote

💵 $165.6k - $248.4k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

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• Open for 12 days.
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Boehringer Ingelheim

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim is a global, research-driven, family-owned pharmaceutical company headquartered in Germany that discovers, develops, manufactures, and markets prescription medicines, biopharmaceuticals, vaccines, and animal health products. The company focuses on therapeutic areas including respiratory, cardiovascular, metabolic, oncology, immunology, and zoonotic diseases, and invests heavily in R&D and biotechnology to advance drug discovery and development. It operates worldwide across both human pharmaceuticals and animal health markets, partnering with academic institutions and biotech firms to translate scientific research into therapies.

📋 Description

• 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 and 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 • Develop document and submission timelines and strategies • Resolve and integrate review comments • Coordinate cross-functionally to ensure timely and successful document finalization • Ensure quality and timeliness of clinical 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 in-depth 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

• 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 project medical writer • Demonstrated expertise in regulatory writing, including protocols, clinical trial reports of early clinical phases, investigator’s brochures, and other clinical documents on study- and project-level • 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 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 for target audiences • Ability to comprehend and interpret clinical data • Ability to manage projects effectively 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 • Expertise in the assigned therapeutic area and its clinical standards, including new medical or statistical approaches

🏖️ Benefits

• Role-specific discretionary bonus eligibility • Relocation assistance • Medical coverage • Dental coverage • Vision coverage • Retirement savings opportunities • Paid time off • Paid holidays • Disability insurance • Life insurance • Other company-sponsored benefits • International collaboration opportunities • Meaningful work, mobility, networking and work-life balance support

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