Director, Medical Writing
$198K - $297K/yr
The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical ...
$198K - $297K/yr
The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical ...
$198K - $297K/yr
The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical ...
Sioux Falls, SD · On-site +1
$190K - $230K/yr
The Director, Medical Writing - Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting ...
Sioux Falls, SD · On-site +1
$190K - $230K/yr
The Director, Medical Writing - Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting ...
Waltham, MA · On-site
$220K - $235K/yr
The Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing ...
Waltham, MA · On-site
$220K - $235K/yr
The Director, Medical Writing provides strategic and operational leadership for medical writing activities across one or more clinical development programs. This role combines hands-on writing ...
Foster City, CA · Hybrid
$230K - $245K/yr
POSITION SUMMARY Director, Medical Writing works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service ...
Foster City, CA · Hybrid
$230K - $245K/yr
POSITION SUMMARY Director, Medical Writing works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service ...
Portland, OR · Remote
$164K - $273K/yr
Remote Stryker is hiring a Manager, Medical Writing for our Endoscopy division. This is a remote position based in the United States. As the Manager, Medical Writing you will support clinical ...
Portland, OR · Remote
$164K - $273K/yr
Remote Stryker is hiring a Manager, Medical Writing for our Endoscopy division. This is a remote position based in the United States. As the Manager, Medical Writing you will support clinical ...
Portland, OR · On-site
$164K - $273K/yr
Remote Stryker is hiring a Manager, Medical Writing for our Endoscopy division. This is a remote position based in the United States. As the Manager, Medical Writing you willsupport clinical ...
Portland, OR · On-site
$164K - $273K/yr
Remote Stryker is hiring a Manager, Medical Writing for our Endoscopy division. This is a remote position based in the United States. As the Manager, Medical Writing you willsupport clinical ...
Advancing healthcare with heart Job Summary Sr. Manager Medical Writing, manages and oversees the work of medical writing teams to support clinical and regulatory submissions (e.g., clinical ...
Advancing healthcare with heart Job Summary Sr. Manager Medical Writing, manages and oversees the work of medical writing teams to support clinical and regulatory submissions (e.g., clinical ...
San Diego, CA · On-site +1
Department: 107050 Medical Writing Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere ...
New
San Diego, CA · On-site +1
Department: 107050 Medical Writing Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere ...
New
San Diego, CA · On-site +1
Department: 107050 Medical Writing Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere ...
New
San Diego, CA · On-site +1
Department: 107050 Medical Writing Location: San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere ...
New
Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities * Leads the Medical Writing contributions to assigned therapeutic area(s). Key ...
Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities * Leads the Medical Writing contributions to assigned therapeutic area(s). Key ...
Somerset, NJ · On-site
Advancing healthcare with heart Job Summary Sr. Manager Medical Writing, manages and oversees the work of medical writing teams to support clinical and regulatory submissions (e.g., clinical ...
Somerset, NJ · On-site
Advancing healthcare with heart Job Summary Sr. Manager Medical Writing, manages and oversees the work of medical writing teams to support clinical and regulatory submissions (e.g., clinical ...
Managing focus o Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents o Author ...
Managing focus o Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents o Author ...
Associate Director, Medical Writing Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!) * Relocation Assistance Available About the Opportunity Our client is ...
Associate Director, Medical Writing Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!) * Relocation Assistance Available About the Opportunity Our client is ...
Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities * Leads the Medical Writing contributions to assigned therapeutic area(s). Key ...
Senior Medical Writer(s) and Medical Writer(s) will report to this role Main Responsibilities and Accountabilities * Leads the Medical Writing contributions to assigned therapeutic area(s). Key ...
Manhattan, NY · On-site
Our client is seeking its first Director of Medical Writing to establish and lead the medical writing function at a critical stage of clinical and regulatory advancement. Reporting to the SVP of ...
New
Manhattan, NY · On-site
Our client is seeking its first Director of Medical Writing to establish and lead the medical writing function at a critical stage of clinical and regulatory advancement. Reporting to the SVP of ...
New
Associate Director, Medical Writing (Hybrid - SF Bay Area) We are seeking an experienced Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory ...
Associate Director, Medical Writing (Hybrid - SF Bay Area) We are seeking an experienced Associate Director of Medical Writing to lead the development of high-quality clinical and regulatory ...
Durham, NC · On-site
$160K/yr
Trilogy Writing & Consulting, an Indegene company, is currently looking to hire a Medical Writing Manager/Senior Manager, reporting directly to the Director of Medical Writing, to support our growing ...
Durham, NC · On-site
$160K/yr
Trilogy Writing & Consulting, an Indegene company, is currently looking to hire a Medical Writing Manager/Senior Manager, reporting directly to the Director of Medical Writing, to support our growing ...
Associate Director, Medical Writing Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!) * Relocation Assistance Available About the Opportunity Our client is ...
Associate Director, Medical Writing Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!) * Relocation Assistance Available About the Opportunity Our client is ...
Associate Director, Medical Writing Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!) * Relocation Assistance Available About the Opportunity Our client is ...
Associate Director, Medical Writing Location: Hybrid 4 days/week in South San Francisco, CA (2 remote flex days per month!) * Relocation Assistance Available About the Opportunity Our client is ...
Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document generation and maintenance. This position will lead ...
Vaxcyte is seeking a Director, Clinical Medical Writing to drive and shape the medical writing processes, procedures, strategies, and document generation and maintenance. This position will lead ...
$11.54 - $17.66
0% of jobs
$17.66 - $23.78
8% of jobs
$23.78 - $29.90
12% of jobs
$32.80 is the 25th percentile. Wages below this are outliers.
$29.90 - $36.01
11% of jobs
$36.01 - $42.13
11% of jobs
The median wage is $44.87 / hr.
$42.13 - $48.25
20% of jobs
$54.04 is the 75th percentile. Wages above this are outliers.
$48.25 - $54.37
15% of jobs
$54.37 - $60.49
13% of jobs
$60.49 - $66.61
7% of jobs
$66.61 - $72.73
2% of jobs
$72.73 - $78.85
2% of jobs
$11
$46
$78
| Aspect | Medical Writing | Medical Editing |
|---|---|---|
| Required Credentials | Typically requires a background in life sciences, healthcare, or related fields; often a degree or certification in medical writing | Requires strong knowledge of medical terminology and writing; often a background in healthcare, editing, or related fields |
| Work Environment | Often works independently or in teams, creating clinical documents, regulatory submissions, and educational materials | Usually works alongside writers, reviewing and refining medical documents for clarity, accuracy, and consistency |
| Employer & Industry Usage | Used in pharmaceutical, biotech, healthcare, and medical device industries | Common in publishing, healthcare communications, and regulatory agencies |
Medical Writing involves creating original medical content such as clinical study reports, regulatory documents, and educational materials. Medical Editing focuses on reviewing and refining these documents to ensure clarity, accuracy, and compliance. Both roles require strong medical knowledge, but Medical Writers produce content, while Medical Editors improve existing content.
Medical writing jobs work in health care and science communities to compose documents and articles. Those who have medical writing jobs may draft many different kinds of papers, such as educational or promotional literature, medical abstracts for textbooks, or research documents. Other medical writing jobs include ghost-writing for prominent scientists or physicians, journalistic writing for scientific magazines, or creating content for marketing materials. Regardless of what field you are in, to obtain medical writing jobs, you must be able to decipher and interpret complicated information and write in a manner that your audience understands. For example, you may use medical jargon in scientific journals, but medical writers typically use simpler language when writing for the general public.
$198K - $297K/yr
Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 21 days ago
Lead the planning and authoring of complex strategic clinical and regulatory documents, including clinical trial protocols, amendments, clinical study reports, and investigator's brochures.
Oversee the preparation of clinical overviews, summaries for regulatory submissions, Health Authority briefing books, responses, and scientific publications.
Lead the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance.
At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
Role:
The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical documentation to support the conduct of trials and regulatory submissions/filings.Â
The Director, Medical Writing participates in the development of templates and the establishment of medical writing processes and standards to ensure the quality and timeliness of regulatory filings and clinical documentation, in accordance with relevant regulatory guidelines and requirements. This role collaborates with the other members of the Medical Writing Leadership Team to manage the planning, oversight, and execution of the Medical Writing portfolio, drive strategic initiatives, and identify development areas within Medical Writing.Â
Responsibilities:
Document Creation and Review:Â
Lead the planning and authoring of complex strategic clinical and regulatory documents, including clinical trial protocols, amendments, clinical study reports, and investigator’s brochures.Â
Oversee the preparation of clinical overviews, summaries in CTD/eCTD format for regulatory submissions, Health Authority briefing books, responses, and scientific publications (abstracts, posters, slide presentations, and manuscripts).Â
Team Leadership and Collaboration:Â
Represent medical writing on internal teams such as the Clinical Development Team and/or Clinical Trial Team, protocol review committee, regulatory submission teams, and ad-hoc working groups to support company initiatives.Â
Independently lead cross-departmental submission teams, ensuring high performance standards and compliance with regulatory requirements.Â
Mentor new employees and consultants and serve as a role model for junior writers.Â
Guide medical writing staff during the planning and execution stages across all document types and regulatory submissions.Â
Process Development:Â
Lead the development, review, implementation, and improvement of departmental processes, policies, standard operating procedures, training, and work guidance.Â
Initiate and drive strategic Medical Writing initiatives and processes to ensure alignment with company priorities.Â
Manage the oversight of Medical Writing vendors/CROs, ensuring high performance standards are met.Â
Regulatory and Quality Adherence:Â
Maintain up-to-date knowledge of relevant regulatory guidelines and requirements.Â
Ensure adherence to guidelines, SOPs, practices, and technical standards in all aspects of work.Â
Professional Development:Â
Maintain current knowledge and competencies within relevant therapeutic and professional areas.Â
Contribute to knowledge sharing, skill-building, and good collaboration with stakeholders and colleagues.Â
Requirements:
Bachelor's degree in science or related area; Master's/advanced degree preferred
12+ years in clinical or regulatory medical writing in biotech/ pharma industry or 15+ years of relevant, cumulative biotech/pharma industry experience with at least 10 years regulatory Medical Writing experience
Oncology experience required
Significant experience in writing/leading the writing of critical clinical documents in major regulatory filings (NDA, BLA, MAA)
Advanced familiarity with all phases of drug development and a clinical operations organization
Significant experience in working with drug development processes, Good Clinical Practice (GCP), regulatory requirements and guidelines associated with all regulatory documents (including CTA/IND submissions, protocols, investigator brochures, and clinical study reports)
Significant experience managing/guiding internal cross-functional teams
Experience in managing a functional team/overseeing the work of other writers/CROs/vendors
Proven performance in earlier role/comparable role
For US based candidates, the proposed salary band for this position is as follows:
$198,240.00---$297,360.00The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.Â
When you join Genmab, you’re joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expensesÂ
About You
You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so!
Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.