Job Details
Medical Writing Operations QC Manager (Remote)
Job Description
General Summary:
The Medical Writing Operations Manager is responsible for QC review of regulatory and clinical study documents, including clinical study reports and protocols and day-to-day operations of the Medical Writing Associates group. The Manager focuses on planning and resourcing work within the group, and applies technical expertise to develop solutions to complex problems. In addition, the Manager is expected to contribute to the development, implementation, and maintenance of processes for Medical Writing.
Key Duties and Responsibilities:
- Prepares and delivers effective presentations for internal and external audiences, as needed
- Participates in discussions regarding Medical Writing process strategy
- Maintains a high level of knowledge related to current developments in the field, including pharmaceutical regulations pertaining to documentation for regulatory submissions
- Has solid technical and analytical skills and is able to recommend changes to or troubleshoot systems
- Continually evaluates and improves processes
- Contributes to the design of functional area goals
- Provides Medical Writing management with updates on resourcing and metrics
- Performs other duties as assigned
Education and Experience:
- Master's Degree and 4+ years of relevant work experience, or Bachelor's Degree and 6+ years relevant work experience
Pay Range: 100,000.00 - 145,000.00 annually
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
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Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [Register to View]