Manager/Senior Manager, Medical Writing
Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative solutions in women’s health and prostate cancer. We are currently seeking a qualified, highly motivated, experienced individual for the position of Manager/Senior Manager, Medical Writing. The position reports to the Director, Medical Writing. The location of the position is in Brisbane, CA.
The Manager/Senior Manager, Medical Writing will be responsible for writing and coordinating the development of clinical and regulatory documents, including clinical study reports and summaries of clinical data for inclusion in marketing applications (eg, NDAs, BLAs). This is an individual contributor position. The Manager/Senior Manager, Medical Writing will work closely with cross-functional teams to ensure that documents are of high quality and are completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The individual must have the ability to work both independently and as an effective, engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest standards of ethics and professionalism is required.
Essential Duties & Responsibilities
- Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing to the standards of the house style guide, and managing various documentation processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
- Work closely with internal and external resources to ensure alignment with timelines and data communication plans
- Write, edit, contribute to, and manage the development of a variety of clinical and regulatory documents (e.g., clinical study reports, eCTD/NDA clinical summaries, investigator brochures, clinical trial protocols and amendments, briefing books, IND applications)
- Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
- Partner with subject matter experts and other stakeholders to oversee document review and comment resolution meetings with cross-functional teams
- 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
- Perform literature-based research to support writing activities
- Contribute to 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
- 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; adapts work style to meet organization needs
- 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
- Daily demonstrates a positive, “can-do” and service-oriented attitude. 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
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- 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)
Communication & Interpersonal Skills
- Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Employees across the Roivant companies, visitors
- BS, MS, or doctorate, preferably in a scientific or medical field
- At least 5 years of experience in Medical Writing
- Minimum of 7 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.
Equal Employment Opportunity