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Associate Director Medical Writing Jobs (NOW HIRING)

Jj

Associate Director, Medical Education

Santa Clara, CA · On-site +1

Position Overview The Associate Director, Medical Education is a critical, high-visibility customer ... Effective written, verbal and presentation skills with all levels of management and organizations.

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Associate Director Medical Writing information

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How much do associate director medical writing jobs pay per year?

As of Aug 12, 2026, the average yearly pay for associate director medical writing in the United States is $164,797.00, according to ZipRecruiter salary data. Most workers in this role earn between $121,500.00 and $200,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as an associate director medical writing?

To thrive as an Associate Director Medical Writing, you need advanced knowledge of clinical research, regulatory requirements, and scientific writing, typically supported by a life sciences degree and extensive medical writing experience. Familiarity with document management systems, regulatory submission platforms, and guidelines such as ICH and FDA is crucial. Outstanding leadership, attention to detail, and strong communication skills help manage teams and ensure clarity in complex scientific documents. These competencies are vital for producing high-quality regulatory documents that meet industry standards and support successful drug development.

How does an associate director medical writing typically collaborate with cross-functional teams during the drug development process?

As an Associate Director of Medical Writing, you will frequently collaborate with regulatory affairs, clinical development, biostatistics, and medical affairs teams to ensure the accuracy and compliance of regulatory documents. This role often involves leading writing teams, managing timelines, and synthesizing input from subject matter experts to produce high-quality submissions. Effective communication and project management skills are crucial, as you’ll coordinate review cycles, address feedback, and ensure consistency across documents. These cross-functional interactions are essential for meeting regulatory requirements and supporting successful drug submissions.

What does an associate director medical writing do?

An Associate Director of Medical Writing leads a team of medical writers in creating and reviewing scientific documents for regulatory submissions, publications, and clinical studies. They ensure accuracy, compliance with guidelines, and high-quality content while managing timelines and collaborating with cross-functional teams such as clinical, regulatory, and biostatistics departments. This role often involves mentoring junior writers, overseeing project workflows, and providing strategic input on document development. Their work plays a critical role in the successful communication of clinical research findings and regulatory submissions.

Is there a demand for associate director medical writing?

The role of associate director medical writing is in high demand due to the growth of the pharmaceutical and biotech industries, which require skilled professionals to develop regulatory documents, clinical study reports, and scientific publications. Candidates with strong writing skills, industry knowledge, and familiarity with regulatory guidelines like ICH and FDA are sought after, especially in organizations emphasizing compliance and quality. The demand is expected to remain steady as drug development and approval processes continue to expand globally.

What is the difference between Associate Director Medical Writing vs Medical Writer?

AspectAssociate Director Medical WritingMedical Writer
QualificationsAdvanced degree (MD, PhD, PharmD), extensive experience in medical writingBachelor's or Master's degree in life sciences or related field
Work EnvironmentLeads teams, manages projects, collaborates with cross-functional teamsPrepares clinical and regulatory documents, works under supervision
ResponsibilitiesStrategic oversight, team management, high-level reviewDrafts and edits clinical/regulatory documents, supports project teams

The Associate Director Medical Writing typically holds advanced degrees and has leadership responsibilities, overseeing teams and strategic projects. Medical Writers usually have relevant scientific degrees and focus on producing high-quality documents under supervision. The roles differ mainly in scope, responsibility, and level of experience required.

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What cities are hiring for Associate Director Medical Writing jobs? Cities with the most Associate Director Medical Writing job openings:
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Associate Director Medical Writing jobs near you
Infographic showing various Associate Director Medical Writing job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, and 9% Contract. Highlights an 36% In-person, 18% Hybrid, and 46% Remote job distribution, with an average salary of $164,797 per year, or $79.2 per hour.

Sr. Director, Medical Writing - Biologics

SAB

Sioux Falls, SD • Remote

$190K - $260K/yr

Full-time

Re-posted 23 days ago

Job description

The Sr. Director, Medical Writing – Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage development and anticipated commercialization of SAB’s lead biologic candidate, SAB-142, and broader pipeline programs. This role requires deep expertise in biologics regulatory writing, including leadership of Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and global regulatory submissions to the FDA, EMA, and other international health authorities. The ideal candidate will bring extensive experience supporting late-phase biologics programs within agile biotech environments, with a demonstrated ability to drive submission readiness, support commercial launch planning, and partner cross-functionally to advance programs through regulatory approval and commercialization.
  • Lead cross-functional development of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) to support global regulatory submissions and benefit-risk assessments.
  • Provide strategic leadership for submission readiness activities, including pre-BLA planning, regulatory milestone preparation, and inspection-ready documentation strategies.
  • Experience operating within lean, fast-paced biotech environments with high individual accountability and accelerated submission timelines.
Duties and Responsibilities (Include but are not limited to):
  • Lead medical writing activities for biologic products across clinical development and regulatory submission programs.
  • Author, review, and finalize high-quality regulatory documents including:
    • Biologics License Applications (BLA)
    • Supplemental BLAs (sBLA)
    • Integrated Summaries of Safety (ISS)
    • Integrated Summaries of Efficacy (ISE)
    • Marketing Authorization Applications (MAA)
    • Clinical Study Reports (CSRs)
    • Investigator Brochures (IBs)
    • Protocols and protocol amendments
    • Clinical summaries and overviews
    • FDA and EMA briefing documents
    • Responses to Health Authority questions
    • Advisory Committee briefing materials
    • Labeling negotiation and product information documents
    • Submission gap assessments and remediation documentation
    • Module 2 summaries and other CTD/eCTD components
  • Direct and execute end-to-end medical writing strategy for global biologics regulatory submissions, including BLA, MAA, and lifecycle management activities.
  • Influence and align cross-functional stakeholders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, Translational Sciences, CMC, and Executive Leadership teams to ensure consistent regulatory strategy and messaging. Ensure documents comply with ICH, GCP, FDA, EMA, and other global regulatory guidelines.
  • Ensure consistency of scientific messaging, pooled data interpretation, and benefit-risk positioning across all submission components.
  • Manage timelines, resources, and deliverables for complex submission activities. Lead submission readiness tracking, document planning, and cross-functional coordination for major filing milestones and regulatory deliverables.
  • Drive consistency, quality, and strategic messaging across submission documents. Contribute to process improvements, document standards, templates, and medical writing best practices as SAB continues to scale.
  • Provide vendor oversight to third party medical writers.  Manage medical writer(s) who may be hired as SAB moves closer to BLA filing.  
  • Collaborate closely with Regulatory Operations and Publishing teams to ensure technically compliant, inspection-ready eCTD submissions across global regions. Actively participate in regulatory strategy discussions and provide writing expertise during agency interactions.
  • Support key regulatory interactions including pre-BLA meetings, late-cycle reviews, advisory committee preparation, and responses to agency information requests.
  • Support lifecycle management activities including supplemental filings, annual reports, post-marketing commitments, and safety update documentation.
  • Support due diligence activities for potential partnerships, licensing discussions, and investor-facing regulatory communications, as needed.
Supervisory Responsibilities:
This position does not have supervisory responsibilities at this time.  Supervisory responsibilities may be added at a future date.
Education/Experience/Skills:
  • 12+ years of medical writing experience in biologics development within the biotech or pharmaceutical industry required.
  • Advanced degree: PhD, PharmD, MD, MS, in Immunology or related discipline
  • Experience with successful FDA and EMA approvals for biologic products preferred but not required.
  • Significant and demonstrated experience supporting biologic drug development programs through medical writing activities.
  • Demonstrated hands-on experience authoring and leading BLA and MAA submissions is required, including having led at least one BLA submission.
  • Demonstrated experience leading late-stage regulatory submission activities through filing, review, and approval phases is strongly preferred.
  • Experience supporting expedited regulatory pathways, including Fast Track, Breakthrough Therapy, Orphan Drug, RMAT, and Priority Review, preferred.
  • Proven experience in preparing and managing:
    • Clinical Study Reports (CSRs)
    • FDA regulatory dossier submissions
    • Global regulatory submissions for biologic products
    •  Integrated summaries (ISS/ISE)
    • NDA/BLA submission readiness and governance activities
    • Advisory Committee preparation support
  • Strong knowledge of:
    • FDA and EMA regulatory requirements
    • ICH guidelines
    • CTD/eCTD structure and submission standards
    • Deep understanding of late-stage clinical development and commercialization transition activities for biologic products.
  • Demonstrated leadership and influence within cross-functional matrix organizations, including the ability to drive alignment across competing priorities in fast-paced biotech settings. Work on multiple complex projects simultaneously and provide quality work product within deadlines.
Preferred Leadership Competencies:
  • Strong regulatory judgment and ability to proactively identify submission risks and mitigation strategies.
  • Ability to synthesize complex scientific and clinical data into clear, concise, and strategically aligned regulatory narratives.
  • Experience operating successfully in lean biotech organizations with evolving priorities and compressed timelines.
High degree of ownership, accountability, and execution focus.
  • Excellent written scientific writing, editing, and communication skills.  Ability to verbally articulate scientific and related information to wider groups and stakeholders.
Physical Demands:  
While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee must regularly lift and/or move up to 10 pounds. 
Working Environment and Travel:
Home office working environment.
Occasional business related travel is expected.
ADA: 
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets​
 

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