What are the responsibilities and job description for the Medical Writing Science Manager (Hybrid) Job at Vertex Pharmaceuticals in Boston position at Mediabistro?
Job Description
Vertex is hiring experienced Clinical Regulatory Medical Writers to join our world-class Medical Writing team in Boston.
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.
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 :
Education and Experience :
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
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