Job Description
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:
- Superior written and oral communication skills.
- Experience writing and editing clinical regulatory documents.
- Ability to analyze, interpret, and summarize moderately complex data.
- Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.
- Ability to manage project teams, form productive working relationships, and work through conflicts.
- Excellent project management and organizational skills.
- Ability 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 issues.
- Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process.
- Advanced 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 tools.
Education and Experience:
- MS, Ph.D. (or equivalent degree).
- Typically requires 4 years of experience or the equivalent combination of 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.
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