Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions. We are on a mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. We are looking for passionate and enthusiastic individuals who share our excitement for this mission.
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Medical Writing Operations Manager. This position reports to the Senior Manager, Medical Writing Operations. The preferred location of the position is Brisbane, CA but flexibility is possible for the right candidate.
The individual will be primarily responsible for the quality control review of regulatory clinical documents. This includes managing the quality control review of regulatory clinical documents, verifying accuracy of data, and review and proofreading of content for accurate use of grammar, punctuation, and style in compliance with Myovant Style Guide. Responsibilities can grow to include other key deliverables within Medical Writing Operations and across Medical Writing overall.
Essential Duties and Responsibilities
- Manage/perform quality control review of regulatory clinical documents (eg, safety narratives, clinical study reports, protocols and amendments, informed consent forms, common technical documents, product labels, etc.) according to agreed-upon timelines and follow-up with team and vendors to meet internal and external timelines
- Verify data accuracy in regulatory clinical documents and verify that all QC findings are adequately addressed
- Using Myovant’s QC checklist, verify consistency of text with internal document data displays, as well as external reference sources
- Review and edit regulatory clinical documents; statistical tables, listings, and figures; and statistical analysis plans for accuracy of grammar and style, ensuring the documents adhere to Myovant Style Guide, templates, and conventions
- Support the Medical Writing Operations group with the review and QC of clinical trial registration and results postings and other tasks as needed
- Build strong relationships with internal and external medical writers and other project team members to ensure high-quality work and timely delivery of QCed documents
- Other projects when assigned
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decisions that are appropriate for the organization
- Are results-driven, take initiative and ownership to accomplish work
- Have flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
REQUIREMENTS (Education and Experience)
- Bachelor of Science/Bachelor of Arts in Life Sciences, English or equivalent combination of education and experience
- Minimum 5+ years of relevant experience as an editor or proofreader of technical written materials (biotech or pharmaceutical industry preferred); experience writing or substantive editing of such materials a plus
- Sophisticated knowledge of English usage (grammar, punctuation, language usage, and experience working with American Medical Association Manual of Style)
- Regulatory Affairs and/or Clinical Development experience is preferred
- Strong management, project management, and critical thinking skills
- Demonstrated experience in medical writing, editing, and proofreading in regulatory affairs and/or clinical development; previous work on safety narratives, clinical study reports, protocols and amendments, informed consent forms, common technical documents, product labels
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
If you require any accommodations, please email firstname.lastname@example.org.
Equal Employment Opportunity