Medical Writing Science Senior Manager - Boston, United States - Vertex Pharmaceuticals, Inc

Vertex Pharmaceuticals, Inc Boston, United States

2 weeks ago

Description

Job Description

At Vertex, Our Medical Writing Scientists are strategic partners in the drug development process, collaborating with cross functional teams to bring new, innovative, life-changing products to patients.

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.

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:

D. (or equivalent degree)

Typically requires 6 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.

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

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