Clinical & Regulatory Medical Writing Director (Hybrid)) - Vertex Pharmaceuticals
Boston, MA 02108
About the Job
Job DescriptionOur Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.The Medical Writing Director has responsibility for the management, oversight, operation, and direction of Clinical Regulatory Writing in support of our Pain program
This role is expected to optimize interdisciplinary understanding & teamwork, and integrate activities with those of other groups in Medical Writing Science and cross-functional teams.This is a hybrid position which allows for 2 days per week remote work, and 3 days per week onsite at our Boston Fan Pier office.Key Duties and Responsibilities:Independently authors routine and complex clinical and regulatory documentsAdvises development teams on the content and optimal presentation of documents to facilitate achievement of submission objectivesProvides strategic input into program-level and therapeutic area plans, including defining the direction of the clinical development program or regulatory strategiesOptimizes interdisciplinary understanding and synergy within group(s) and integrate activities with those of other department and project teamsManages resource plans for projects within their oversight ensuring appropriate staff are available to meet program goalsProvides coaching and mentorship for junior staff membersPlans strategically, anticipates problems, and recommends process improvements to address current and future needsProvides expert review of policies and procedures for the departmentInnovates and leads process improvements with high cross-functional impactKnowledge and Skills:Highly advanced understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissionsProven track record of developing, communicating, and executing strategic direction for projectsStrong leadership and influencing skills, ability to communicate and present ideas/solutions to senior managementAbility to recognize business impact and identify networks to gain unified approach to solutionsDemonstrated knowledge of fieldExperience with marketing applications for regulatory submissionsEducation and Experience:Ph.D
(or equivalent degree)Typically requires 10 years of work experience and 3 years of mentorship/supervisory experience, or the equivalent combination of education and experience#LI-AR1#LI-HYBRIDFlex 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.Company 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
This role is expected to optimize interdisciplinary understanding & teamwork, and integrate activities with those of other groups in Medical Writing Science and cross-functional teams.This is a hybrid position which allows for 2 days per week remote work, and 3 days per week onsite at our Boston Fan Pier office.Key Duties and Responsibilities:Independently authors routine and complex clinical and regulatory documentsAdvises development teams on the content and optimal presentation of documents to facilitate achievement of submission objectivesProvides strategic input into program-level and therapeutic area plans, including defining the direction of the clinical development program or regulatory strategiesOptimizes interdisciplinary understanding and synergy within group(s) and integrate activities with those of other department and project teamsManages resource plans for projects within their oversight ensuring appropriate staff are available to meet program goalsProvides coaching and mentorship for junior staff membersPlans strategically, anticipates problems, and recommends process improvements to address current and future needsProvides expert review of policies and procedures for the departmentInnovates and leads process improvements with high cross-functional impactKnowledge and Skills:Highly advanced understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissionsProven track record of developing, communicating, and executing strategic direction for projectsStrong leadership and influencing skills, ability to communicate and present ideas/solutions to senior managementAbility to recognize business impact and identify networks to gain unified approach to solutionsDemonstrated knowledge of fieldExperience with marketing applications for regulatory submissionsEducation and Experience:Ph.D
(or equivalent degree)Typically requires 10 years of work experience and 3 years of mentorship/supervisory experience, or the equivalent combination of education and experience#LI-AR1#LI-HYBRIDFlex 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.Company 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
ApplicationAssistance@vrtx.comSummaryLocati
on: Boston, MAType: Full time
Source : Vertex Pharmaceuticals