Job Description
General Summary:
The Medical Writing Science Senior Manager is responsible for independently authoring complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. This role may represent Medical Writing Science as a cross-functional team member for study-level and program-level activities.
This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office.
Key Duties and Responsibilities:
Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, documents to support meetings with regulatory agencies, and sections of marketing authorization applications) in partnership with key stakeholders.
Serves as the lead Medical Writing Scientist for complex or pivotal clinical studies for multiple programs or therapeutic areas.
Provides expert review of study-level and program-level documents.
Participates in developing key messages for complex clinical regulatory documents.
Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program.
Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline.
Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents.
Ensures document preparation is compliant with company and industry standards.
Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies.
Knowledge and Skills:
Outstanding written and oral communication skills.
Extensive experience writing and editing clinical regulatory documents.
Ability to analyze, interpret, and summarize highly complex data.
Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions.
Highly developed project management and organizational skills.
Ability to manage challenging, high-value projects.
Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes.
Education and Experience:
Bachelor's degree in relevant discipline.
Ph.D. (or equivalent degree).
Typically requires 6 years of experience or the equivalent combination of education and experience.
#LI-AR1#LI-Hybrid
Pay Range:
$0 - $0
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 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 persons 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