Job Description
The Medical Writing Operations Senior Specialist is primarily responsible for independently performing in-depth quality control (QC) reviews on moderately complex clinical and regulatory documents across multiple therapeutic disease areas. The Sr. MWOS provides QC expertise to the MW Operations team and supports MW Scientists to prepare high quality and compliant documents by assisting with essential tools and technologies.
KEY RESPONSIBILITIES:
- Independently performs content, editing, and formatting QC of moderately complex regulatory and clinical study documents, which may include complex CSRs, complex protocols, Investigator Brochures, and single study Module 2 summaries
- Ensures QC reviewed documents are compliant with MWS Style guide and templates
- Troubleshoots MWS processes, tools, and technologies and may serve as subject matter expert
- Uses electronic document management systems (EDMS) to retrieve QC sources and track document dependencies, such as appendices for clinical study reports
- Assists MW Scientists with the collection and maintenance of literature references in Endnote
- Contributes to MWS initiatives related to QC, document development, or process improvement (i.e., new tools or systems)
- Works cross functionally to communicate responsibilities and track deliverables for complex CSR Appendices
- Travels to corporate headquarters in Boston up to 1 week per quarter
TECHNICAL AND COMMUNICATIVE SKILLS:
- Able to work effectively in a remote environment
- Exceptional attention to detail
- Advanced proficiency with Microsoft Office (including Word, PowerPoint, and Excel) and the use of templates
- Expertise using Endnote for citation management
- Experience with using in-house style guide standards for editing and formatting
- Working knowledge of clinical development and regulatory affairs documentation
- Experience retrieving and filing documents within an electronic document management system
- Excellent interpersonal, verbal, and written skills with ability to effectively manage stakeholders
- Conscientious, self-motivated, organized, and able to independently manage multiple projects with aggressive timelines
- Solves routine problems of with limited supervision and adapts to new work requests with minimal instruction
REQUIRED EXPERIENCE:
- A minimum of 4 years of relevant work experience in review and QC of complex clinical and regulatory documents.
Pay Range: 81,600.00 - 122,400.00 USD 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.
#LI-AR1
#LI-Remote
Pay Range:
$81,600 - $122,400
Disclosure Statement:
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.
Flex Designation:
Remote-Eligible
Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
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.
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 ApplicationAssistance@vrtx.com
