New · posted Oct 31
Mirum Pharmaceuticals · Pharmaceuticals
Principal Medical Writer
- Foster City, CA
- Hybrid
- Full-time
- Senior & Principal
The role
Principal Medical Writer 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.
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.
What you need
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.
Pay
$230,000 – $245,000 a year
Employer providedThe 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.
Where you'll work
Foster City, CAHybridOpen in Maps (opens in a new tab)
More jobs in Foster City, CAWorking conditions
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.
Equal opportunity, accessibility and legal noticesMirum Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 28% above the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Senior & Principal roles in the US6 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $230,000 | — | $245,000 |
| All US (middle half) | $162,375 | $186,000 | $205,875 |
This role: Mirum Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 21 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Mirum Pharmaceuticals's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 15 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership5
- Documentation and SOPs4
- Regulatory submissions2
- Clinical trial conduct2
- GMP and compliance1
- Investigations and CAPA1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Mirum Pharmaceuticals on Regulatory Jobs
- 9
- Open roles
- 9
- Distinct roles
- 1
- Locations
By discipline
- Regulatory5 56%
- Quality2 22%
- Clinical2 22%
By level
- Director5 56%
- VP & Executive2 22%
- Manager1 11%
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