Medical Writing Manager (Hybrid)

Job DescriptionGeneral 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 stakeholdersServes as the lead Medical Writing Scientist for moderately complex clinical studiesSupports Medical Lead with review and interpretation of clinical study data and addressing questions from study team membersParticipates in developing key messages for moderately complex clinical regulatory documentsEnsures medical and scientific consistency between related documents or studies in a clinical programAnalyzes and interprets data thoroughly and critically to determine the best approach to composing each documentContributes 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 plansParticipates in developing standard operating processes and related proceduresKnowledge and Skills:Superior written and oral communication skillsExperience writing and editing clinical regulatory documentsAbility to analyze, interpret, and summarize moderately complex dataBroad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminologyAbility to manage project teams, form productive working relationships, and work through conflictsExcellent project management and organizational skillsAbility 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 issuesInitiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional processAdvanced 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 toolsEducation and Experience:Ph.D. (or equivalent degree)Typically requires 4 years of experience or the equivalent combination of education and experience#LI-AR!#LI-HybridPay Range:$120,200 - $180,400Disclosure 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 EligibleFlex 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-HybridCompany InformationVertex 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 View email address on click.appcast.io: Boston, MAType: Full time