--- title: 'Principal Medical Writer at Mirum Pharmaceuticals' canonical: 'https://feeny.ai/job/principal-medical-writer-mirum-pharmaceuticals-foster-city-edncamrtfvb7' type: 'job' last_seen: '2026-09-09' --- # Principal Medical Writer at Mirum Pharmaceuticals - **Company:** Mirum Pharmaceuticals - **Location:** Foster City, CA - **Posted:** 2026-05-01 - **Last confirmed live:** 2026-09-09 - **Apply:** https://job-boards.greenhouse.io/mirumpharmaceuticals/jobs/5126677007 ## 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 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. ## 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. ## About Mirum Pharmaceuticals ## Company Overview - **One-liner**: Mirum Pharmaceuticals is a global biopharmaceutical company focused on developing and delivering treatments for rare liver diseases affecting children and adults with significant unmet medical needs. - **Entity Type**: Public (NASDAQ: MIRM) - **Headquarters**: Foster City, California, USA - **Founded**: 2018 - **Founders**: Not publicly listed as individual founders; the company was established by a leadership team with deep rare disease and biotech experience who identified a deprioritized therapy for Alagille syndrome and moved decisively to advance it. ## Core Business - **Primary industry/industries**: Biotechnology / Rare Disease Pharmaceuticals - **Target customers**: Healthcare providers, patients, and families affected by rare liver diseases (Alagille syndrome, Progressive Familial Intrahepatic Cholestasis, and other cholestatic conditions); B2B relationships with payers, distributors, and healthcare systems globally. - **Mission or purpose statement**: "Relentlessly Rare" — focused on conditions where the burden is profound and the need is greatest, combining deep expertise with disciplined execution to advance meaningful medicines for people around the world. ## Products & Services - **LIVMARLI® (maralixibat)**: An oral, once-daily ileal bile acid transporter (IBAT) inhibitor approved for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC). Approved in multiple regions including the US and Europe. Additional development programs are underway. - **Pipeline Programs**: A broad pipeline of investigational medicines targeting significant unmet needs in rare liver diseases, including additional indications for LIVMARLI and other early-stage programs. ## Market Standing - **Valuation/Market Cap**: As of mid-2025, Mirum’s market capitalization is approximately $1.5–$2.0 billion (fluctuating with stock price; check current data on [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx)). - **Key Metric**: Annual Revenue — Mirum generates revenue from commercial sales of LIVMARLI. In 2024, the company reported total revenue of approximately $290 million (preliminary figure; verify in latest 10-K). The company has transitioned from a development-stage to a commercial-stage biotech. - **Notable Investors/Partners**: Public institutional investors; key partners include clinical sites, patient advocacy groups (e.g., Alagille Syndrome Alliance, PFIC Network), and global distribution partners for international markets. - **Growth Signals**: Three approved medicines in its portfolio; global footprint with offices in North America and Europe; expanding pipeline with additional clinical programs; consistent revenue growth from LIVMARLI; growing commercial presence in Europe and other regions. ## Competitive Advantages - **First-in-class / Best-in-class therapy**: LIVMARLI is the first and only approved treatment for cholestatic pruritus in Alagille syndrome, addressing a critical unmet need with no prior approved therapies. - **Deep rare disease expertise**: The leadership team has extensive experience in rare disease drug development, regulatory strategy, and commercialization, allowing the company to navigate complex pathways efficiently. - **Patient-centric culture**: Mirum embeds patient and family voices directly into development and commercial strategy, ensuring therapies meet real-world needs. - **Disciplined execution**: The company was founded with a single deprioritized asset and rapidly advanced it to approval, demonstrating agility and focus. ## Strategic Focus - **Expand global access**: Continuing to secure regulatory approvals and market access for LIVMARLI and other pipeline assets across North America, Europe, and other regions. - **Advance pipeline**: Pursuing additional indications for LIVMARLI and developing new therapies for other rare liver diseases with high unmet need. - **Deepen patient engagement**: Strengthening relationships with patient communities and advocacy groups to inform research, development, and commercialization. - **Build commercial infrastructure**: Expanding commercial, medical affairs, and patient services teams globally to support growing product portfolio. ## Why Work Here - **Mission-driven culture**: Mirum’s core values — "Care, Be Real, Get It Done, and Have Fun, Seriously" — foster a collaborative, high-performance environment where employees are empowered to bring their authentic selves to work. - **Flexible work environment**: The company supports flexible ways of working, with offices in Foster City (global HQ), Basel (Switzerland), and Zug (Switzerland), plus US Remote roles available for certain positions. Arrangements vary by role. - **Comprehensive benefits**: 100% employee medical premium coverage (with 100% dependent medical contributions), 4% 401(k) match with immediate vesting, 15% Employee Stock Purchase Plan, four weeks of PTO starting day one, company holidays including a winter shutdown, paid parental leave, up to $5,000 annual tuition reimbursement, and an Employee Assistance Program. - **Collaborative community**: Regular "Coffee and Chats" and bi-weekly "Lunch Connections" foster cross-functional dialogue. Office environments are designed for connection with stocked snacks, beverages, and (in some locations) catered lunches and on-site baristas. - **Growth opportunity**: As a high-growth public company with approved products and an expanding pipeline, employees have significant opportunities to contribute to meaningful milestones and career development. ## Sources 1. [mirumpharma.com](https://mirumpharma.com/) 2. [mirumpharma.com/about-us/our-story/](https://mirumpharma.com/about-us/our-story/) 3. [mirumpharma.com/jobs/](https://mirumpharma.com/jobs/) 4. [ir.mirumpharma.com](https://ir.mirumpharma.com/overview/default.aspx) 5. 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