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.

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