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 qualified, highly motivated, experienced individual for the position of Senior Manager, Medical Writing. The position reports to the Director, Medical Writing. The location of the position is in Brisbane, CA.
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).
The Senior Manager, Medical Writing is expected to be able to work flexibly, either independently with minimal to no supervision or in support of one or more subject-matter expert authors, as needed. The Senior Manager, Medical Writing is expected to be able to advise and collaborate with cross-functional colleagues on document strategy, authoring and review processes, best practices, and solutions to emergent challenges in developing documents that will allow Myovant to meet document timelines with a high level of quality in compliance with SOPs, ICH/GCP/regulatory guidelines, and company goals. Maintaining confidentiality and operating with the highest of ethical standards and professionalism are required.
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, Knowledge, and Skill Requirements
- Demonstrated experience in medical writing and editing in the context of clinical drug development; previous work on CSRs and clinical data summaries required;
- Demonstrated ability to work effectively in a fast-paced environment with multiple high-priority projects;
- Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support;
- Flexible (eg, adapts work style to meet organization needs, able to shift priorities quickly while working under tight deadlines);
- Ability to develop and implement medical writing processes and standards;
- Exceptional oral and written communication skills;
- Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues;
- Strong organizational abilities and experience in a multitasking environment;
- Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals;
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings are essential and required;
- Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction;
- Strong oral and written communicator; detail-oriented with a commitment to accuracy;
- Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks;
- Skilled in developing collaborative internal and external relationships;
- Required skill in the operation of standard office equipment including: fax machines, copy machines, and other equipment as necessary
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint);
- Familiar with the AMA Manual of Style, common commercial templates and template software, electronic document management systems, and the Transcelerate and CORE templates.
- Bachelor’s degree in a scientific or medical field or in English, journalism, or writing is required.
- Advanced degree in a scientific or medical field is a plus.
- At least 5 years of experience in Medical Writing is preferred;
- Minimum of 3 years in the biotechnology/pharmaceutical industry is preferred.
TRAVEL, PHYSICAL DEMANDS, AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Close vision required for computer usage
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
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 email@example.com.
Equal Employment Opportunity