Associate Director, Medical Writing – Experimental Medicine

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $165.6k - $248.4k / year

⏰ Full Time

🟠 Senior

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 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

• 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

• 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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume