Description
At CVS Health, we’re building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care.
Position Summary
The Medical Affairs Clinical Evidence Medical Writer will play a pivotal role to support the execution of a strategic portfolio through the development of clinical evidence that demonstrates the effectiveness of our products, programs, and services. This position will 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).
This position will be a key member in research workstreams to 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), and support additional steps throughout the Medical Affairs governance process for clinical publications. Under the direction of Principal Investigators, the candidate will work with biostatisticians, clinicians, researchers, and other stakeholders to effectively and accurately communicate findings to a variety of audiences and be able to support its creative design. The candidate will ensure all evidence deliverables are generated in accordance with internal best practices, regulatory guidelines, and clinical research and medical writing standards. This position will also support the maintenance of a clinical evidence repository.
This role will develop content and documentation required for tracking processes and communicate evaluation status on a regular basis for all parties involved. It will also 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.
This position will 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.
Required Qualifications
- 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.
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.
- Oustanding 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.
Education
- Bachelor’s degree in medical-related, life sciences, or relevant field (required).
- Master’s degree or higher in medical-related, life sciences, or relevant field (preferred).