Manager, Medical Writing

Danaher Corporation

5d • $130 - $160 • Remote

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives. Learn about the Danaher Business System which makes everything possible. The Manager, Medical Writing, is responsible for leading and developing the medical writing team for Danaher Diagnostics, overseeing the creation of high-quality clinical and regulatory documents for submission in the US and EU markets. You will manage a team of experienced medical writers, many with clinical backgrounds (MDs), ensuring scientific accuracy, regulatory compliance, and timely delivery of essential documentation to support clinical studies and product registrations. This position within the Clinical Center of Excellence (CCOE) reports to the Senior Director, Clinical Compliance and Medical Writing, and will be fully remote. In this role, you will have the opportunity to: Lead, mentor, and performance manage a team of Medical Writers, providing guidance on document development, scientific content, and regulatory requirements for both US and EU submissions. Oversee the planning, writing, editing, and quality control of a wide range of clinical and regulatory documents, including technical documentation for CE-IVDR/MDR, summaries, and responses to notified body questions, but also could include clinical study protocols, clinical study reports (CSRs), Investigator's Brochures (IBs), and similar documentation, as needed by the Clinical Development teams. Ensure all medical writing activities and documents comply with Good Clinical Practice (GCP), relevant US (e.g., FDA) and EU (e.g., IVDR/MDR, EMA guidelines) regulatory guidelines, ICH guidelines, and company Standard Operating Procedures (SOPs). Manage medical writing timelines and resources, ensuring timely delivery of high-quality documents to meet clinical study milestones and regulatory submission deadlines in both the US and EU. Serve as a subject matter expert on medical writing best practices, document standards, for the US and EU. Collaborate effectively with cross-functional teams including CCOE Clinical Development, Biostatistics, Data Management and Operating Company partners in Regulatory Affairs, Quality Assurance, Medical & Scientific Affairs and R&D to gather necessary input and ensure scientific accuracy and consistency across documents. Implement continuous improvement to medical writing processes, templates, and standards to improve efficiency, consistency, and quality within the team, leading with DBS and leveraging AI in accordance with company policies.

Requirements

• Bachelor’s degree in a scientific, medical, or related field with 7+ years’ experience in medical writing within the pharmaceutical, biotechnology, diagnostics, or medical device industry, with significant experience preparing documents for US and EU regulatory submissions, or a Masters or Doctoral degree (MD, PhD, PharmD) with 4+ years of same experience.
• 3+ years direct leadership experience managing a team of medical writers or other scientific/clinical professionals.
• Demonstrated expert understanding of medical writing principles, styles, and standards (e.g., ICH guidelines, GCP).
• Demonstrated strong knowledge of US FDA and EU regulatory requirements and guidance related to clinical and regulatory documentation (e.g., FDA guidance, IVDR/MDR requirements, EMA guidelines).
• Experience working with clinical study data (including statistical output) and interpreting complex scientific and clinical information for inclusion in regulatory documents.
• Proven ability to lead and develop a remote team of highly skilled professionals.
• Ability to travel <10%, as needed for DBS events and initiatives

Nice To Haves

• Previous experience specifically in the diagnostics medical device industry preparing documentation requirements under IVDR.
• Experience managing medical writers with advanced clinical degrees (e.g., MDs).
• Experience with submission, review and publication of peer-reviewed journal articles.

Responsibilities

• Lead, mentor, and performance manage a team of Medical Writers, providing guidance on document development, scientific content, and regulatory requirements for both US and EU submissions.
• Oversee the planning, writing, editing, and quality control of a wide range of clinical and regulatory documents, including technical documentation for CE-IVDR/MDR, summaries, and responses to notified body questions, but also could include clinical study protocols, clinical study reports (CSRs), Investigator's Brochures (IBs), and similar documentation, as needed by the Clinical Development teams.
• Ensure all medical writing activities and documents comply with Good Clinical Practice (GCP), relevant US (e.g., FDA) and EU (e.g., IVDR/MDR, EMA guidelines) regulatory guidelines, ICH guidelines, and company Standard Operating Procedures (SOPs).
• Manage medical writing timelines and resources, ensuring timely delivery of high-quality documents to meet clinical study milestones and regulatory submission deadlines in both the US and EU.
• Serve as a subject matter expert on medical writing best practices, document standards, for the US and EU.
• Collaborate effectively with cross-functional teams including CCOE Clinical Development, Biostatistics, Data Management and Operating Company partners in Regulatory Affairs, Quality Assurance, Medical & Scientific Affairs and R&D to gather necessary input and ensure scientific accuracy and consistency across documents.
• Implement continuous improvement to medical writing processes, templates, and standards to improve efficiency, consistency, and quality within the team, leading with DBS and leveraging AI in accordance with company policies.

Benefits

• Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
• The annual salary range for this role is $130-160k. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees