Job Description
Senior Director, Medical Writing (Hybrid)
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Senior Director, Medical Writing (Hybrid)
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General Summary:
Our 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.
This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available.
Job Description
General Summary: Our 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. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Relocation assistance is available.
The Senior Director, Medical Writing Science has responsibility for the management, oversight, operation, and direction of a larger group within the department. The Senior Director is a key stakeholder working with cross-functional teams to provide scientific, clinical, and strategic input throughout the lifecycle of an asset. This role may be responsible for multiple programs and/or disease areas, including executing strategic clinical regulatory and scientific publications and for defining cross functional goals and plans.
Key Duties And Responsibilities - Oversight of Medical Writing Science team responsible for the development of clinical documents, regulatory documents, and scientific publications (abstracts, posters, oral presentations, manuscripts) across the lifecycle of an asset
- Provides scientific, clinical, and strategic input for an asset(s) in clinical development within a portfolio for one or more disease areas
- Provides strategic input to global marketing authorization applications and responses to health and regulatory authorities
- Provides expertise and input to help author and communicate visually compelling scientific publications for medical congresses and journals
- Leads internal governance bodies with high cross-functional impact (e.g., Protocol Governance Committee)
- Represents Medical Writing Science in Inspection Readiness and participates in GCP Audits and Inspections
- Mentors staff on professional development, motivates personnel, and resolves conflicts
- Manages resource plans for programs within their oversight ensuring appropriate staff are available to meet program goals
- Advises on optimizing process improvements for the department
- Plans strategically, anticipates problems, and recommends process improvements to address current and future needs
Knowledge And Skills - In-depth knowledge of industry requirements and best practices policies for clinical regulatory documents and scientific publications (e.g., GCP, GPP, ICH, ICMJE)
- Robust understanding of the clinical development process and preparation of the clinical sections of marketing applications and other regulatory submissions
- Robust understanding of disciplines beyond their discipline
- Distinguished record of developing, communicating, and executing strategic direction for projects
- Effective leadership skills with ability to influence at higher levels
- Excellent written and oral communication skills
- Ability to manage teams and individuals
Education And Experience - Typically requires Ph.D. in a relevant scientific field
- Typically requires 12 years of work experience and 5 years of supervisory/management experience, or the equivalent combination of education and experience
#Hybrid
Pay Range $219,200 - $328,800
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:
- Hybrid: work remotely up to two days per week; or select
- On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs 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
Seniority level
Employment type
Employment type
Full-time
Job function
Job function
Health Care Provider
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Job Tags
Full time, Work experience placement, Summer work, Work at office, Remote work, Relocation package, Flexible hours, 2 days per week, 3 days per week,