Medical Writer

Medical Writer

Requirements

• 5+ years of experience as a Medical Writer.
• Relevant work experience writing deliverables in healthcare and/or clinical research and supporting project management of cross-functional teams with large research portfolios with concurrent studies
• Prepare, edit, and finalize protocols, synposes, regulatory documents and related clinical documents such as abstracts, posters, presentations, and manuscripts
• Participate in scientific communication planning, including development of strategic medical communication plans and timeline development
• Partner with colleagues to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings, and narrative planning for relevant documents
• Schedule and conduct document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
• Ensure appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
• Demonstrated experience with research protocols and regulatory bodies, Institutional Review Board requirements, and Good Clinical Practices
• Demonstrated experience in clinical research execution to interpret study results and collaborate with stakeholders in the development of clinical evidence development content
• Demonstrated success publishing in scientific/clinical conference proceedings and major scientific journals
• Bachelor’s degree in medical-related, life sciences, or relevant field

Responsibilities

• Support the execution of a strategic portfolio through the development of clinical evidence that demonstrates the effectiveness of products, programs, and services
• Work directly with the Executive Director of Clinical Evidence Development (CED) to design, develop, support, and manage cross-enterprise evidence generation from ideation through drafting and submission of clinical evidence deliverables (e.g., manuscripts, conference abstracts, and white papers)
• Prepare or assist in the preparation of study protocols from cross-functional teams
• Manage IRB submissions
• Critically analyze content for data validity and integrity
• Draft evidence deliverables (e.g., manuscripts, conference abstracts, white papers, decks, posters, podium presentations, visual abstracts)
• Support additional steps throughout the Medical Affairs governance process for clinical publications
• Develop content and documentation required for tracking processes and communicate evaluation status on a regular basis for all parties involved
• Provide consultative support as needed, develop and present communications to effectively describe Clinical Evidence Development strategy and key considerations for timely project launch and completion
• Work closely with CVS cross-enterprise partners from Analytics & Behavior Change, Product Teams (e.g., Digital, Virtual Care, etc), Health Equity Office, Medical Management, and other stakeholders to execute clinical evidence deliverables as part of an enterprise-wide evidence development strategy to impact clinical / scientific communications internally and externally

Preferred Qualifications

• Master’s degree or higher in medical-related, life sciences, or relevant field
• Experience with real-world data sources, study design, and evidence generation
• Demonstrated ability to provide analytical review of clinical content management to ensure data integrity and validity
• Relevant experience to support the development, maintenance, and querying of a clinical evidence repository
• Excellent oral / written communication skills following the prioritization, identification, critical appraisal, and development of clinical evidence
• Strict attention to detail
• Outstanding time management skills; demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines
• Demonstrated experience working independently and as part of a team
• Excellent interpersonal relationship skills including negotiating and relationship management skills with the ability to drive achievement of objectives
• Certified Society of Clinical Research Associate or Association of Clinical Research Professionals certification
• Good Clinical Practice certification
• Responsible Conduct of Research certification
• Human Subjects Research certification
• Research Study Design certification
• Experience with Knowledge Management (e.g., EndNote, Electronic Databases) systems