What are the responsibilities and job description for the Senior Manager, Medical Writing position at Myovant Sciences?
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.
Summary Description
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Medical Writing located at our Brisbane office and will consider remote option for the right candidate. The Senior Manager, Medical Writing is responsible for writing, editing, supporting cross-functional review and adjudication, and coordinating the completion of regulatory and other documents related to Myovant’s drug development programs, including but not limited to clinical study protocols and amendments, statistical analysis plans, regulatory agency briefing books, clinical study reports, and clinical, nonclinical, and/or CMC summaries for marketing applications (eg, NDAs, BLAs, MAAs).
Essential Duties and Responsibilities
- Write, edit, contribute to, and manage the development of a variety of clinical regulatory documents, as well as other documents per Myovant’s business needs
- Ensure smooth and effective document management from start to finish (ie, from template to final approved version), including but not limited to first draft authoring, coordination of review and adjudication, reference retrieval, generation of bibliographies, adherence to the Myovant style guide, and participating in various document processes (eg, QC, formatting, publishing, archiving)
- Work closely with internal and external resources to ensure alignment among timelines for related activities, such as data communication, document authoring, document review, QC, publishing, and submission
- Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives, as required, ensuring adherence to applicable standards and requirements
- Partner with subject matter experts and other stakeholders to oversee document review and comment adjudication meetings with cross-functional teams
- Support the development, implementation, and improvement of best practices, the document process, and SOPs
- Help communicate procedure, operations, and implementation plans to the organization
- Distill large amounts of clinical and scientific data into summary text and analysis for clinical documents
- Perform literature-based research to support writing activities
- Develop and maintain templates and outlines for key documents
- Perform other duties, as assigned.
Core Competencies
- Demonstrate communication and collaboration skills with an ability to manage and influence stakeholders in a matrix environment effectively
- Exercise good judgment and make decision that is appropriate for the organization
- Results-driven, take initiative and ownership to accomplish work
- Ability to demonstrate flexibility and embrace change in a dynamic, rapidly growing environment
- Strive for continuous improvement and embrace innovative ideas in daily work
- Ability to develop and implement medical writing processes and standards
REQUIREMENTS (Education and Experience)
- Bachelor of Science/ Bachelor of Arts in a relevant scientific discipline
- Advanced degree in a scientific or medical field is a plus
- Minimum 8 years of relevant experience in biotech or pharmaceutical industry
- Demonstrated experience in medical writing and editing in the context of clinical drug development; previous work on CSRs and clinical data summaries required
- Familiar with the AMA Manual of Style, common commercial templates and template software, electronic document management systems, and the Transcelerate templates
The well-being and safety of our employees is our top priority. Myovant Sciences requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
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 careers@myovant.com.
Equal Employment Opportunity