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.As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues - caring for people where, when and how they choose in a way that is uniquely more connected, more convenient and more compassionate. And we do it all with heart, each and every day.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
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- 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
- 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
- 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)
40Time Type
Full timePay Range
The typical pay range for this role is:$66,330.00 - $145,860.00This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.Great benefits for great peopleWe take pride in our comprehensive and competitive mix of pay and benefits - investing in the physical, emotional and financial wellness of our colleagues and their families to help them be the healthiest they can be. In addition to our competitive wages, our great benefits include:
- Affordable medical plan options, a 401(k) plan (including matching company contributions), and an employee stock purchase plan.
- No-cost programs for all colleagues including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching.
- Benefit solutions that address the different needs and preferences of our colleagues including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility.