Mirum focuses on finding and developing drugs for difficult to treat liver diseases. Our lead program is focused on two severe liver diseases in children, Alagille Syndrome and progressive familial intrahepatic cholestasis (PFIC). Both conditions can result in severe itching, liver damage and a need for liver transplant. Based on a wealth of data from clinical trials spanning multiple years and involving more than one hundred patients, we believe our approach can address the underlying cause of symptoms and liver damage. Our goal is to give families their lives back.
Reporting to the Executive Director, Regulatory Affairs, the Medical Writer works closely with stakeholders in Clinical Development, Biostatistics and other functional areas to develop internal and external Regulatory documents, including but not limited to, clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summary reports, NDA/MAA and eCTD submissions, and Investigator Brochures, IND’s, NDA materials etc.
- Work collaboratively to incorporate/adjudicate comments from internal and external stakeholders through document development to produce final high-quality deliverables.
- Participate in the writing, editing, and confirmation of the scientific and medical accuracy of clinical and regulatory documents.
- Critically analyze complex data and information and collaborate with clinical, medical, and biostatistics/data science teams on data analysis, description, and presentation.
- Collaborate other vendors to develop related graphics and figures.
- Interact with internal stakeholders and with external service providers to ensure the timely development, review, and publication of documents.
- Have a demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
- Write and coordinate the development of protocols, CSRs or other clinical and regulatory documents including those of a more complex nature.
- Ensure quality control of documents as well as formatting finalization.
- Provide support in development of submission level documents under guidance of senior staff.
- Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget across compounds and indications while managing external vendors.
- To prioritize and plan workload to 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 inter-department working groups.
- An advanced degree with minimum of 5 years of experience in medical writing in the pharmaceutical, biotech, medical communication agency.
- 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 styling guide.
- Strong proficiency in word, excel, power point 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 the 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.
- This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
Please submit your resume to email@example.com