Clinical Regulatory Medical Writing Manager; Hybrid
Position: Clinical Regulatory Medical Writing Manager (Hybrid)
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. Relocation assistance is available. 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: $136,700 - $205,100 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… Apply tot his job Apply To this Job