ASSOCIATE DIRECTOR - REGULATORY AND MEDICAL WRITING SUMMARY: The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and ...
ASSOCIATE DIRECTOR - REGULATORY AND MEDICAL WRITING SUMMARY: The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and ...
ASSOCIATE DIRECTOR - REGULATORY AND MEDICAL WRITING SUMMARY: The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and ...
ASSOCIATE DIRECTOR - REGULATORY AND MEDICAL WRITING SUMMARY: The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and ...
Associate Director, Regulatory and Medical Writer
Carlsbad, CA · On-site
$142.59 - $201.47/hr
Associate Director, Regulatory and Medical Writer Job Category: Development - Ionis Requisition Number: IONIS003873 Posted: July 15, 2026 Employment Type: Full-Time Locations: Carlsbad, California;
Associate Director, Regulatory and Medical Writer
Carlsbad, CA · On-site
$142.59 - $201.47/hr
Associate Director, Regulatory and Medical Writer Job Category: Development - Ionis Requisition Number: IONIS003873 Posted: July 15, 2026 Employment Type: Full-Time Locations: Carlsbad, California;
ASSOCIATE DIRECTOR, MEDICAL WRITING Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer andmultiple tumor types. Leveraging therapeutics development and ...
ASSOCIATE DIRECTOR, MEDICAL WRITING Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer andmultiple tumor types. Leveraging therapeutics development and ...
Associate Director Medical Writing
San Diego, CA · On-site
$180K - $220K/yr
ASSOCIATE DIRECTOR, MEDICAL WRITING Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and ...
Associate Director Medical Writing
San Diego, CA · On-site
$180K - $220K/yr
ASSOCIATE DIRECTOR, MEDICAL WRITING Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and ...
Associate Director, Medical Writing
San Diego, CA · On-site +1
The Associate Director, Medical Writing is responsible for oversight and authoring (if needed) of regulatory submissions (Common Technical Documents [CTD]), as well as other regulatory, clinical, and ...
Associate Director, Medical Writing
San Diego, CA · On-site +1
The Associate Director, Medical Writing is responsible for oversight and authoring (if needed) of regulatory submissions (Common Technical Documents [CTD]), as well as other regulatory, clinical, and ...
Associate Director, Medical Writing
San Diego, CA · On-site
$120 - $150/hr
San Diego, USA - Remote Position Summary The Associate Director, Medical Writing is responsible for oversight and authoring (if needed) of regulatory submissions (Common Technical Documents [CTD ...
Associate Director, Medical Writing
San Diego, CA · On-site
$120 - $150/hr
San Diego, USA - Remote Position Summary The Associate Director, Medical Writing is responsible for oversight and authoring (if needed) of regulatory submissions (Common Technical Documents [CTD ...
Associate Director, Medical Writing
South San Francisco, CA · On-site
$230K - $240K/yr
Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory ...
Associate Director, Medical Writing
South San Francisco, CA · On-site
$230K - $240K/yr
Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory ...
The Associate Director of Medical Writing will be responsible for leading the development of key regulatory and clinical documents supporting the company's drug development programs, while also ...
The Associate Director of Medical Writing will be responsible for leading the development of key regulatory and clinical documents supporting the company's drug development programs, while also ...
Associate Director, Medical Writing
South San Francisco, CA · On-site
$230K - $240K/yr
Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory ...
Associate Director, Medical Writing
South San Francisco, CA · On-site
$230K - $240K/yr
Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory ...
Senior Medical Writing Lead, Regulatory Submissions Remote
San Diego, CA · On-site
$120 - $150/hr
Travere Therapeutics in San Diego is looking for an Associate Director, Medical Writing to oversee regulatory submissions and manage related documentation. This role requires at least 6 years of ...
Senior Medical Writing Lead, Regulatory Submissions Remote
San Diego, CA · On-site
$120 - $150/hr
Travere Therapeutics in San Diego is looking for an Associate Director, Medical Writing to oversee regulatory submissions and manage related documentation. This role requires at least 6 years of ...
Associate Director, Medical Writing
San Diego, CA · On-site
$140 - $200/hr
* Provide strategic and operational medical writing expertise to prepare high-quality complex clinical and regulatory documents for health authority submissions. * Contribute to the medical and ...
Associate Director, Medical Writing
San Diego, CA · On-site
$140 - $200/hr
* Provide strategic and operational medical writing expertise to prepare high-quality complex clinical and regulatory documents for health authority submissions. * Contribute to the medical and ...
Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a reliable contributor across cross-functional teams. The ...
Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a reliable contributor across cross-functional teams. The ...
Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a reliable contributor across cross-functional teams. The ...
Reporting to the Associate Director, Medical Writing, this individual is a capable, hands-on author of clinical and regulatory documents and a reliable contributor across cross-functional teams. The ...
Associate Director, Medical Writing & Scientific Communications
San Diego, CA · On-site
$170K - $190K/yr
The Associate Director, Medical Writing & Scientific Communications will be a key member of the Medical Affairs organization, responsible for developing and executing strategic scientific ...
Associate Director, Medical Writing & Scientific Communications
San Diego, CA · On-site
$170K - $190K/yr
The Associate Director, Medical Writing & Scientific Communications will be a key member of the Medical Affairs organization, responsible for developing and executing strategic scientific ...
Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year ...
Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year ...
Associate Scientific Writer - Medical Devices
Rancho Santa Margarita, CA · On-site
$70K - $80K/yr
Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year ...
Associate Scientific Writer - Medical Devices
Rancho Santa Margarita, CA · On-site
$70K - $80K/yr
Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year ...
Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year ...
Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year ...
Associate Medical Director/Medical Director, Endocrinology and Metabolism
Redwood City, CA · On-site
$200K - $269K/yr
The Associate Medical Director/Medical Director, will act as a key participant in the medical and ... in the writing and review of clinical protocols, investigator brochures, clinical study reports ...
Associate Medical Director/Medical Director, Endocrinology and Metabolism
Redwood City, CA · On-site
$200K - $269K/yr
The Associate Medical Director/Medical Director, will act as a key participant in the medical and ... in the writing and review of clinical protocols, investigator brochures, clinical study reports ...
ASSOCIATE MEDICAL DIRECTOR
Livermore, CA · On-site
The Associate Medical Director (AMD) plays a key leadership role in ensuring high-quality, patient ... Excellent writing, business communication, editing, and proofreading skills. * Ability to interact ...
ASSOCIATE MEDICAL DIRECTOR
Livermore, CA · On-site
The Associate Medical Director (AMD) plays a key leadership role in ensuring high-quality, patient ... Excellent writing, business communication, editing, and proofreading skills. * Ability to interact ...
Associate Medical Writer information
See California salary details
$14 - $17.92
3% of jobs
$17.92 - $21.85
9% of jobs
$25.69 is the 25th percentile. Wages below this are outliers.
$21.85 - $25.77
13% of jobs
$25.77 - $29.70
7% of jobs
$29.70 - $33.62
8% of jobs
$33.62 - $37.55
5% of jobs
The median wage is $39.27 / hr.
$37.55 - $41.47
8% of jobs
$41.47 - $45.40
16% of jobs
$46.91 is the 75th percentile. Wages above this are outliers.
$45.40 - $49.32
12% of jobs
$49.32 - $53.25
7% of jobs
$53.25 - $57.17
11% of jobs
$13
$38
$57
How much do associate medical writer jobs pay per hour?
What are the key skills and qualifications needed to thrive as an associate medical writer?
What are some common challenges faced by associate medical writers during their first year on the job?
What is the difference between Associate Medical Writer vs Medical Writer?
| Aspect | Associate Medical Writer | Medical Writer |
|---|---|---|
| Required credentials | Bachelor's degree, often in life sciences or related field | Bachelor's or higher degree, often with some experience |
| Work environment | Entry-level, training-focused, often in pharmaceutical or biotech companies | More independent, involved in complex document creation for regulatory or scientific purposes |
| Employer usage | Pharmaceutical, biotech, medical communications agencies | Pharmaceutical companies, CROs, medical communication firms |
The main difference between an Associate Medical Writer and a Medical Writer lies in experience and responsibility. Associate Medical Writers are typically entry-level, focusing on learning and supporting document preparation, while Medical Writers handle more complex projects independently. Both roles require similar educational backgrounds and are common in the pharmaceutical and biotech industries.
What does an associate medical writer do?

Full-time
Re-posted 24 days ago
Job description
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!
ASSOCIATE DIRECTOR - REGULATORY AND MEDICAL WRITING
SUMMARY:
The Associate Director, Medical Writing is responsible for leading the planning, development, and delivery of complex clinical and regulatory documents in support of global regulatory submissions and development programs.
This role provides strategic leadership within the Regulatory and Medical Writing function, serving as a key partner to Clinical Development, Biostatistics, and other cross-functional teams to ensure high-quality, scientifically rigorous, and compliant regulatory documentation.
The Associate Director will lead medical writing activities across multiple programs, drive document strategy and messaging, and contribute to regulatory submission planning. This position may also mentor and guide other medical writers while ensuring consistency, quality, and adherence to regulatory standards.
This role reports to the Executive Director (Head) of Regulatory and Medical Writing.
This position may be fully remote; however, preference will be given to San Diego-based applicants.
RESPONSIBILITIES:
- Working with the Executive Director, Regulatory and Medical Writing, lead the development, authoring, and delivery of complex regulatory documents such as clinical study reports and marketing application summary documents (Module 2), and lead and/or contribute to Investigator's Brochures, clinical study protocols, and briefing documents.
- Serve as Regulatory Medical Writing lead on cross-functional program teams, partnering with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and other stakeholders.
- Provide strategic input into regulatory document planning and submission strategies to support global regulatory filings.
- Serve as Medical Writing department lead on multiple project/core teams.
- Function as subject matter expert within the department for assigned therapeutic/product areas.
- Responsible for planning (in collaboration with Global Project Management) and leading cross-functional teams to meet timelines for deliverables.
- Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents.
- Understand, assimilate, and interpret sources of information independently.
- Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking).
- Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings.
- Perform quality control (QC) reviews as necessary.
- Interact with Quality Assurance (QA) as document lead to resolve audit findings for specific documents.
- Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation.
- Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.
- Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies.
- Mentor and provide guidance to junior and senior medical writers, contributing to departmental best practices and writing standards.
- Other duties as assigned.
REQUIREMENTS:
- Bachelor's degree required; advanced degree in a scientific, clinical, or regulatory field preferred.
- 12+ years of medical writing experience in the pharmaceutical industry, including marketing applications (e.g., Module 2.5, 2.7.3, 2.7.4). Rare disease experience a plus.
- Proven lead writer experience for key regulatory documents (e.g., CSRs, protocols, IBs, INDs, NDAs, briefing documents), strong expertise in safety sections preferred.
- Demonstrated experience leading medical writing activities for major regulatory submissions, including marketing applications.
- Significant experience as lead writer for Module 2 summary documents (e.g., 2.5, 2.7.1, 2.7.2, 2.7.3, and 2.7.4) and other key regulatory documents.
- Experience writing clinical study reports, Investigator Brochures, clinical protocols, IND/NDA sections, and regulatory briefing documents. In depth experience writing Safety sections of regulatory documents preferred.
- Experience writing requests for regulatory designations (e.g., Breakthrough Designation, Orphan Drug, Sakigake, PRIME, etc) a plus.
- Strong understanding of the drug development lifecycle and regulatory submission processes.
- Extensive knowledge of FDA, EMA, and ICH guidelines (especially ICH E3 and E6[R3]).
- Demonstrated ability to lead cross-functional teams and manage complex document development projects.
- Strong ability to interpret complex scientific and clinical data and translate it into clear regulatory narratives.
- Proficiency in American Meical Association (AMA) style guidelines.
- Advanced attention to detail with expertise in scientific editing, formatting, and document QC.
- Technical proficiency with Microsoft Office and Adobe Acrobat, and document management systems such as Veeva.
- Experience with StartingPoint templates preferred.
- Advanced written and verbal communication skills (including presentations), and project management skills, with the ability to clearly communicate complex scientific concepts across functional teams.
- Extensive experience using style guides, lexicons, and eCTD requirements.
- Demonstrated ability to mentor writers and contribute to a collaborative team environment.
- Energetic, self-motivated, and able to thrive in a dynamic, intense, and fast-paced environment.
- Strong team orientation with the ability to lead initiatives and drive results across cross-functional teams.
- Advanced time-management skills. Ability to balance multiple projects simultaneously.
A brief medical writing exercise may be requested prior to interview.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003873
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our%20employee%20spotlight-,Benefits,-Employees%20are%20rewarded
The pay scale for this position is $142,588 to $201,472
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.