Manager, Medical Writing
Leica Biosystems, New York, NY, United States
Role Summary
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. The position is within the Clinical Center of Excellence (CCOE) and 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.
The Essential Requirements Of The Job Include
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.
Travel, Motor Vehicle Record & Physical/Environment Requirements
Ability to travel
It would be a plus if you also possess previous experience in
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.
Benefits & Compensation
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.
Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home.
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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
Equal Opportunity Employment
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.
#J-18808-Ljbffr
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. The position is within the Clinical Center of Excellence (CCOE) and 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.
The Essential Requirements Of The Job Include
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.
Travel, Motor Vehicle Record & Physical/Environment Requirements
Ability to travel
It would be a plus if you also possess previous experience in
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.
Benefits & Compensation
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.
Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home.
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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
Equal Opportunity Employment
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions and/or to receive other benefits and privileges of employment, please contact: 1-202-419-7762 or applyassistance@danaher.com.
#J-18808-Ljbffr