Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults. Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.
Key Responsibilities: To understand scientific and medical content in given areas of the company. Be able to write, review and edit scientific content for medical writing deliverables. Manage publications vendor and work closely with key internal and external stakeholders. Manage and contribute to global publication plan for the company needs.
- Serve as medical writing lead on scientific medical publications, work effectively with our Medical Communication Agency on publication strategies and deliverables. Learn and apply knowledge of therapeutic area data to scientific publishing projects. Operationally execute all activities to agreed timelines related to the preparation of scientific medical publications (i.e., medical, scientific, and health economics manuscripts, abstracts, posters, and oral presentations).
- Perform literature searches and research areas, as needed, for drafting publication content and make content recommendations for relevant scientific publications.
- Work with relevant internal stakeholders on the development of medical materials for use by field medical affairs team (physician brochures, ecards, medical affairs booth-related materials, slide decks). Assist with Legal Medical Regulatory (LMR) Committee review and approvals.
- Lead the cross-functional publication planning meeting and LMR process for all scientific publication projects.
- Interface with external experts (e.g., physicians, other health care professionals) and effectively collaborate with Clinical Research and Development colleagues, along with other Mirum stakeholders including, but not limited to, compliance, safety, biostatistics, clinical operations and the commercial group to ensure accurate and timely completion/delivery of information, including addressing conflicting demands, and review of scientific publications.
- Serve as a Medical Communication representative on assigned product teams. Communicate deliverables needed, writing process, and timelines to team members.
- Provide direction and guidance to external (agency) medical writers on assigned projects, ensuring a high quality and timely work product.
- Understand, assimilate, and interpret sources of information with appropriate guidance from Chief Scientific Officer (CSO) and Vice President of Medical Affairs, authors, and product team members and internal stakeholders. Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify that results are consistent with study data. Convert relevant data and information into a form that meets publication needs, ensuring required documentation is obtained in adherence to ICMJE and GPP3 guidelines.
- Explain data in manner consistent with the target audience(s) and journal/congress requirements. Confirm completeness of information to be presented. Understand and comply with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress guidelines, and follow Mirum’s Publication Policy and Procedures.
- Develops full understanding of journals and of their submission requirements.
- Tracks key conferences submission deadlines and provide suggestions for submissions to the conferences.
- Identify and propose solutions to resolve issues and questions arising during the writing/review process, including implementing an adjudication process or elevating a concern as appropriate. Ensure project information in publication records and resourcing tools are accurate and up to date.
Knowledge, Skills and Abilities:
- Ability to write scientific materials and synthesize new scientific information.
- Builds strong relationships with internal and external stakeholders.
- Learns fast, grasps the ‘essence’ of a scientific communication deliverables, and can change the course quickly when necessary and indicated.
- Creates an open and inclusive environment for others to provide feedback on scientific communication workstream.
- Embraces the ideas and feedback from others, nurtures free-thinking and innovation.
- Advanced Scientific Degree (Ph.D., Pharm. D) required. Master’s Degree will be considered with significant publication writing experience. Relevant professional certification/credential (e.g., CMPP, AMWA) is a plus.
- 3-5+ years of medical/scientific writing experience in the medical devices/pharmaceutical/health care industry, academia, or related experience (e.g., medical communication agency, clinical/scientific research) is required.
- Excellent organizational, interpersonal, and communications (verbal and written) skills are essential with flawless attention to detail and ability to complete writing assignments in a timely manner with minimal oversight.
- Knowledgeable of US and international regulations, requirements, and guidance’s associated with scientific publications is required.
- Experience in rare disease/hepatology is preferred.
- Working knowledge of statistical concepts and techniques is required.
- Experience in working with fast paced, collaborative, cross-functional teams.
- Must be proficient with Veeva, Microsoft Windows, Word, Excel, and PowerPoint.
- Candidates must be authorized to work in the U.S.
To apply, please send your resume to firstname.lastname@example.org.