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 develop and deliver empowering medicines for women’s health and prostate cancer through purpose-driven science and transformative advocacy. We are looking for passionate and hard-working individuals who share our excitement for this mission.
We are currently seeking a dynamic, highly motivated, experienced individual for the position of Senior Manager/Associate Director, Medical Writing Operations. The position reports to the Head of Medical Writing. The location of the position is in Brisbane, CA, but remote work is possible for the right candidate.
The individual will be responsible for managing efforts in specialized activities supporting Myovant’s programs as part of the Medical Writing group within the Regulatory department. These activities may include, but are not limited to, required postings to clinical trial registries, including clinicaltrials.gov and EudraCT; production of clinical safety narratives; quality control of clinical and nonclinical regulatory documents; redaction of public study documents to protect patient privacy; and compliance with future requirements such as plain-language study summaries.
Essential Duties & Responsibilities
- Ensure that smooth and effective document development takes place from generation of a blank template through a final, approved document. Depending on the document, may require first-draft authoring, reference retrieval, generating bibliographies, editing by use of the Myovant style guide, coordinating contributions from multiple authors, managing complex review and adjudication processes, document formatting, and any other activities necessary for documents and online postings to be completed on time with a high level of quality.
- Work closely with internal and external resources to ensure alignment with timelines and data communication plans
- Manage/perform QC review of regulatory documents and provide QC findings to the designated author
- Support maintenance of study records on ClinicalTrials.gov
- Support the development, implementation, and improvement of the document management process and SOPs; help to communicate procedure, operations, and implementation plan to the organization
- Distill large amounts of clinical and scientific data into essential elements for graphical display
- Distribute work to contract medical writers or agencies
- Develop best practices for authoring and reviewing
- Develop and maintain templates and outlines for key documents
- Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
- Excellent planning and project management skills
- Experience in developing and implementing medical writing processes and standards
- Demonstrated experience in medical writing and editing skills
- Knowledge of regulatory guidelines related to clinical development and regulatory marketing applications
- Demonstrated ability to work independently and effectively in a fast-paced environment with multiple high-priority projects
- Exceptional written and interpersonal communication skills
- Ability to establish and maintain productive relationships with internal and external stakeholders
- Strong organizational skills
- Follow through on commitments
- BS, MS, or doctorate in a scientific or medical field
- Related graduate degrees are preferred
- At least 5 years of experience in Medical Writing, Medical Editing, clinical trials disclosures, and/or document quality control
- Minimum of 7 years in the biotechnology/pharmaceutical industry is preferred
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.
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Equal Employment Opportunity