Clinical & Regulatory Medical Writing Manager

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 authoring & 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:

• Typically requires an MS, Ph.D. (or equivalent degree)
• Typically requires 4+ years of experience authoring clinical & regulatory documents within pharmaceutical or CRO industry (or the equivalent combination of education and experience)

#LI-AR1

#LI-Hybrid

Pay Range:

$120,240 - $180,360

Disclosure Statement:

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex 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 select
2.    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 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 [email protected]