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Reporting to the Director of Medical Affairs, Medical Safety & Writing, this role supports medical communications via advertising and promotion/educational content review to ensure collateral submitted for medical review has been appropriately substantiated and meets requirements. Role is 100% remote.
Job Responsibility:
Conducts initial assessment of materials in Veeva Vault from commercial and physician training teams, verifying that proper support documentation is included for medical reviewers to evaluate promotional, sales training, patient education, physician training, HEOR, and scientific exchange materials across multiple formats
Ensures proper categorization of materials (promotional, disease awareness, HEOR, or scientific exchange), verifies claim substantiation according to company guidelines, and confirms that reference links are clear with appropriate anchors to supporting documentation
Communicates effectively with material authors about necessary changes, reviews materials after medical review to ensure all comments are properly addressed, and completes the approval process with appropriate verdicts (approved with changes, approved, or not approved)
Maintains quality control by checking for brand standards compliance, proper grammar and spelling, appropriate trademark usage, and ensuring citations are correct to avoid plagiarism while reviewing materials across various disease states including peripheral vascular disease, interventional oncology, and end-stage kidney disease
Collaborates with teams outside of Veeva Vault to streamline review processes, attends weekly and ad hoc MLR review meetings virtually, ensures timely document reviews according to project timelines, and maintains professional relationships with other BD associates while complying with all company policies
Requirements:
Bachelor’s degree in life sciences or communication field required
Two years’ experience in health communications, specifically with writing and/or editing and medical terminology, required
Nice to have:
Demonstrated ability to build strong working relationships across matrix organizations and with alliance partners. Comfortable operating in diverse cultural environments with international experience and respected by professional peers in various business and social settings
In-depth knowledge of medical communications, claims management, regulatory requirements (FDA and international), and compliance with company policies regarding promotional and educational materials. Capable of understanding complex legal and technical standards while effectively communicating their intent
Strong background in clinical study design, technical writing, and critical literature appraisal. Proven ability to interpret sophisticated clinical information with knowledge of scientific publications and basic statistics. Experience with disease states including peripheral vascular disease, interventional oncology, and end-stage kidney disease is preferred
Skilled at prioritizing work in evolving environments, working independently with minimal guidance, and providing rapid turnaround to meet business objectives. Demonstrates thorough work with strong attention to detail and precision while serving as a resource for less experienced colleagues
Strong communication skills across verbal, presentation, and written formats. Experience with Veeva Vault and adherence to corporate style guidelines preferred, with AMA Manual of Style experience considered a plus