16 July 2019
Quality Control Manager
Myovant Sciences is a biopharmaceutical startup company focused on delivering innovative women’s health and prostate cancer solutions. We are currently seeking a qualified, highly motivated, experienced individual for the position of Quality Control Manager. The position reports to the AD of Medical Writing Operations.
The Quality Control Manager will be responsible for the quality control review of regulatory clinical documents. This includes managing the quality control review of regulatory clinical documents, review and proofreading of content for accurate use of grammar, punctuation, and style in compliance with Myovant Style Guide, and accuracy of data. The individual must have the ability to work independently and as an effective and 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 of ethical standards and professionalism are required. The Quality Control Manager will provide additional support to the Medical Writing Operation group as needed.
Essential Duties & Responsibilities
- Manage/perform quality control review of regulatory clinical documents (eg, safety narratives, clinical study reports, protocol 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
- 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
- Using Myovant’s QC checklist, verify consistency of text with internal document data displays, as well as external reference sources
- Verify data accuracy in regulatory clinical documents and verify that all QC findings are adequately addressed
- 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
Core Competencies, Knowledge and Skill Requirements
- Demonstrated experience in medical writing, editing, and proofreading in regulatory affairs and/or clinical development; previous work on safety narratives, clinical study reports, protocol and amendments, informed consent forms, common technical documents, product labels
- Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
- Ability to multi-task and shift priorities quickly while working under tight deadlines
- Understands and effectively responds to multicultural communication styles and business practices (in an office setting or via teleconferences) with vendors and internal colleagues
- Flexible; adapts work style to meet organization needs
- 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 is 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
- 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 and 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.
- Bachelor’s Degree in Life Sciences, English or equivalent combination of education and experience
- At least 7 years of experience as an editor or proofreader of technical written materials
- 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
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.
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Equal Employment Opportunity