Top 12 Medical writer Jobs in Foster City, Ca

Director, Medical Writing
Mirum Pharmaceuticals —Foster City, CA
- $230,000 - $245,000 a year
- Hybrid work
- English
- 8 years
- Analysis skills
Regulatory Writer and/or Regulatory QC/ Editor (Temporary)
Vir Biotechnology —San Francisco, CA
- $90 - $120 an hour
- Temporary
- Remote
- 5 years
- Mid-level
- Analysis skills
Quick Apply
Content Writer – Women’s Health & Wellness (Remote)
Bloom health woman —San Francisco, CA
- Up to $10 a day
- Part-time
- Entry level
- Health insurance
- Parental leave
Quick Apply
Manager, Content Strategy and Development (Medical Writing)- Oncology
Gilead Sciences —Foster City, CA
- $146,540 - $189,640 a year
- Full-time
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
- Health insurance
- Dental insurance
Principal Regulatory Writer (Temporary)
Vir Biotechnology —San Francisco, CA
- $180 - $200 a day
- Temporary
- Remote
- 11+ years
- Project management
- Bachelor's degree
Quick Apply
Associate Director, Medical Writing
Acadia Pharmaceuticals Inc. —South San Francisco, CA
- $157,000 - $196,500 a year
- 5 years
- Word processing
- Windows
- Paid parental leave
- Employee stock purchase plan
9d
Director, Medical Writing
Summit Therapeutics —Palo Alto, CA
- $190,000 - $237,000 a year
- Remote
- Bachelor of Science
- Bachelor's degree
- Doctor of Philosophy
Quick Apply
2d
Director, Medical Writing
Maze Therapeutics —South San Francisco, CA
- $223,000 - $271,000 a year
- Hybrid work
- Office
- Bachelor's degree
- Senior level
- Health insurance
- Dental insurance
Quick Apply
Associate Director, Medical Writing
CALICO —South San Francisco, CA
- $230,000 - $240,000 a year
- Master's degree
- 8 years
- Doctor of Philosophy
Director, Clinical Medical Writing
Vaxcyte —San Carlos, CA
- $221,000 - $258,000 a year
- Hybrid work
- 11+ years
- Doctor of Philosophy
- Quality control
Technical Writer - Medical device (Hybrid: Sunnyvale, California) W2 Only
Intuitive —Sunnyvale, CA
- $40 - $70 an hour
- Temporary
- Surgery
- English
- Research
Quick Apply

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Regulatory Writer and/or Regulatory QC/ Editor (Temporary)
Vir Biotechnology —San Francisco, CA
Advanced degree in science or medical field is a plus. Support preparation and inspection‑readiness of technical documents for global regulatory submissions (eg…
$90 - $120 an hour
Quick Apply

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Director, Medical Writing

Mirum Pharmaceuticals
Foster City, CA

Apply Now

Job Details

$230,000 - $245,000 a year

Qualifications

Technical writing for researchers
Medical writing
English
ICH guidelines
Pharmaceutical company experience
Technical Proficiency

Full Job Description

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we're looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

Director, Medical Writing works closely with stakeholders in Clinical Development, Clinical Operations, Biostatistics, and other functional areas and manages medical writing service providers to develop Regulatory documents, including but not limited to clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions, integrated summary reports, NDA/MAA and eCTD submissions, and Investigator Brochures, etc.

JOB FUNCTIONS/RESPONSIBILITIES

Participate in and oversee vendors for the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.
Work collaboratively to incorporate/adjudicate comments from internal and external stakeholders through document development to produce final high-quality deliverables.
Interact with internal stakeholders and with external service providers to ensure the timely development, review, and publication of documents.
Critically analyze complex data and information and collaborate with clinical, medical, and biostatistics/data science teams on data analysis, description, and presentation.
Coordinate the development of the documents named above and others as assigned by the Head of Medical Writing.
Ensure quality control of documents as well as formatting finalization.
Provide support in development of submission-level documents.
Ensure adherence to timelines.
Assist the Head of Medical Writing in coordinating workload and maintaining a high standard. Effectively manage multiple assignments in parallel.
Prepare documents in accordance with Mirum SOP and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
Inform management of medical writing problems promptly and propose solutions.
Provide advice on medical writing issues to project team members (internal and external) and help to resolve problems.
Represent department in audits and interdepartmental working groups.
Develop and maintain in-depth scientific, medical, and technical knowledge relevant to Mirum's clinical studies and pipeline.
Develop strong relationships with external advisors.

QUALIFICATIONS

Education /Experience:

An advanced degree with minimum of 8-10 years of experience in medical writing in the pharmaceutical, biotech, medical communication agency industry.
Excellent writing ability with strong editorial and formatting skills.
Fluency in written and spoken English.
An independently motivated working style with good problem-solving skills that allow analysis, synthesis, and compilation of data from a broad range of disciplines.
Experience managing vendors.
Rare disease or liver disease background highly desirable.

Knowledge, Skills and Abilities:

Have a demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
An ability to work in a fast-paced, cohesive, collaborative team-oriented work environment.
Self-directed and solution oriented.
Extensive knowledge of FDA and ICH regulations and guidelines, as well as familiarity of AMA Style Guide and Chicago Manual of Style.
Strong proficiency in Word, Excel, PowerPoint, and other applications.
Ability to demonstrate a familiarity with principles of clinical research and interpret and present clinical data and other complex information.
A demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines.

The salary range for this position is $230,000 to $245,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee's geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

#LI-HYBRID

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran's status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.

Apply Now

Refine Your Search

medical writer jobs in foster city, ca

Director, Medical Writing

Regulatory Writer and/or Regulatory QC/ Editor (Temporary)

Content Writer – Women’s Health & Wellness (Remote)

Manager, Content Strategy and Development (Medical Writing)- Oncology

Principal Regulatory Writer (Temporary)

Associate Director, Medical Writing

Director, Medical Writing

Director, Medical Writing

Associate Director, Medical Writing

Director, Clinical Medical Writing

Technical Writer - Medical device (Hybrid: Sunnyvale, California) W2 Only

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