Senior Director, Medical Writing

2 weeks ago

Foster City, United States Mirum Pharmaceuticals, Inc. Full time
MISSION Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. 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. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.

POSTION SUMMARY

The Senior Director, Medical Writing is responsible for providing leadership and expertise necessary to develop and execute the overall strategy of the medical writing function. This position is responsible for strategically planning and resourcing the medical writing deliverables that support Mirum’s business objectives for clinical & regulatory development for multiple compounds through all phases of development.

The role will partner with multiple internal groups including Clinical, Regulatory Affairs, Biometrics, Medical Safety, and Non-Clinical to ensure high quality and on-time deliverables that meet regulatory standards. This position drives standardization while providing critical expertise to support program requirements.

JOB FUNCTIONS/RESPONSIBILITIES

  • Oversee all medical writing aspects of R&D programs including coordination, adherence to timelines and budget across compounds and indications while managing external vendors.
  • Direct a team of medical writers (internal and/or consultants) for the authoring and document life cycle of regulatory documents, including clinical protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), electronic Common Technical Document (eCTD) summaries and other documents for submission to the Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory agencies.
  • Liaise with cross-functional team members (e.g., clinical operations, clinical development, regulatory affairs, biostatistics, nonclinical) to ensure high quality and on-time deliverables related to regulatory documents.
  • Direct medical writing team on the compilation, analysis and summary of data from statistical tables and other sources, as needed. Ensure medical writing team is able to critically analyze complex data and information and collaborate with clinical, medical, and biostatistics/data science teams on data analysis, description, and presentation.
  • Oversee medical writing team for the coordination of document reviews; scheduling and hosting of meetings to resolve team comments.
  • Directly interact with internal stakeholders and with external service providers to ensure the final quality control, formatting and timely publication of documents.
  • Prioritize and plan medical writing team workload, including management of multiple assignments in parallel.
  • Identifies and supervises contract writers, as needed.
  • Establish and standardize medical writing practices/systems/tools and direct SOP development and review, departmental initiatives and process improvement.
  • Provide training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.
  • Represent department in audits and interdepartmental working groups.
  • As needed, perform as an individual contributor, participate in the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.

QUALIFICATIONS

Education/Experience:

  • An advanced degree with minimum of 10 years of experience in medical/regulatory writing in the pharmaceutical or biotech industry with at least 3 years of experience leading teams.
  • 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 allowing 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:

  • 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.
  • 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.
  • Ensure that all materials produced are in compliance with current relevant guidelines.
  • Develop and maintain in-depth scientific, medical, and technical knowledge relevant to Mirum’s clinical studies and pipeline.
  • Develop strong relationships with external advisors.
  • A demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines.

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.

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