Medical Writing Manager (Hybrid)

Posted 16 days ago

vertex pharmaceuticalsEast Boston (MA)

Writers and Authors Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

SALARY

$120,200 - $180,400

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About the role

Job Description

General Summary: The Medical Writing Science Manager is responsible for preparing moderately complex clinical and regulatory documents and represents Medical Writing Science as a cross-functional team member at clinical study level activities. This role contributes scientific knowledge and analytical skills to the development of clinical regulatory documentation, under minimal supervision.

Key Duties and Responsibilities:

Authors moderately complex clinical regulatory documents (e.g., including clinical study protocols, clinical study reports, investigator's brochures, and sections of regulatory submissions) in partnership with key cross-functional stakeholders
Serves as the lead Medical Writing Scientist for moderately complex clinical studies
Supports Medical Lead with review and interpretation of clinical study data and addressing questions from study team members
Participates in developing key messages for moderately complex clinical regulatory documents
Ensures medical and scientific consistency between related documents or studies in a clinical program
Analyzes and interprets data thoroughly and critically to determine the best approach to composing each document
Contributes to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serves as coordinating author for product development plans
Participates in developing standard operating processes and related procedures

Knowledge and Skills:

Superior written and oral communication skills
Experience writing and editing clinical regulatory documents
Ability to analyze, interpret, and summarize moderately complex data
Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
Ability to manage project teams, form productive working relationships, and work through conflicts
Excellent project management and organizational skills
Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues
Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process
Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools

Education and Experience: Ph.D. (or equivalent degree) Typically requires 4 years of experience or the equivalent combination of education and experience#LI-AR!#LI-HybridAt Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

Pay Range: $120,200 - $180,400 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: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1.

Hybrid: work remotely up to two days per week; or select2.

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. #LI-Hybrid 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.comSummaryLocation: Boston, MA

Type: Full time

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