Medical and Scientific Reviewer

Benefits

Additional Information

THE POSITION: At EVERSANA, we provide end-to-end integrated global medical information and medical affairs services for various life sciences companies, including pharmaceutical, biotechnology, medical device, digital therapeutics, and over-the-counter companies of various sizes, including industry leaders and emerging companies. Additionally, we provided therapeutic area support across oncology, hematology, rare diseases, immunology, cardiology, dermatology, urology, gastroenterology, infectious diseases, nephrology, neurology, pain, rheumatology, respiratory, ophthalmology, endocrinology, pulmonology, hepatology, consumer products, woman's health and more. This position will be part of our global medical content development and medical / scientific review team. This role requires medical and scientific expertise, an understanding of regulations and best practices for promotional and non-promotional materials, high attention to detail and medical / scientific accuracy, the ability to analyze / translate / interpret scientific literature and data, the ability to quickly learn new therapeutic areas, and excellent communication skills (both verbal and written). ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by: Perform scientific data fact-checking and review of promotional and non-promotional materials that are submitted for medical, legal, and regulatory (MLR) review meetings. Ensure that data are scientifically accurate, contextually correct, editorially accurate, and are presented in a fair/scientifically balanced manner with minimal supervision and in a timely manner: Ensures scientific accuracy, relevance, and completeness of data Ensures claims and data are clinically and statistically relevant and presented in a scientifically balanced manner (not false or misleading) Ensures that claims are adequately supported by data Determines acceptability of references Advises on whether claims are consistent with the approved label Ensure that the piece is relevant and of utility for the target audience Ensure that information and data presented aligns and are consistent with the client's medical strategy for the review of promotional and non-promotional materials across different therapeutic areas and brands to ensure that materials are of high quality and in compliance with applicable laws and regulations, industry standards, and best practices. Review materials, proofread, and check medical content/claims against references. Collaborate and partner with internal or client medical signatory reviewers to ensure alignment and timely and efficient turnaround of material review. Collaborate with material owners / sponsors and other MLR team members to resolve findings, in collaboration with the medical signatory reviewer. Identify, communicate, and resolve issues impacting timelines. Propose recommendations for content and process improvements that could reduce recurring errors and issues. Work with EVERSANA and/or client-provided document management technology platforms (i.e., Veeva PromoMats / MedComms) as content owner when appropriate, uploading documents, and providing reference anchoring and annotations as required. Collaborate with the Head of Medical Content Development / Medical Affairs / Medical Information and contributes to discussions on strategy, tactical execution and communication approaches for assigned projects. Participate in key client meetings as assigned. Support content creation for Medical Affairs, Medical Information, and Medical Communications including, but not limited to, Scientific Response Documents (SRD), Frequently Asked Questions (FAQ) documents, Slide Sets, Abstracts, Posters, Education and Training materials, for current and other potential clients. Support client document development process from gathering materials and developing scientifically rigorous content to facilitating document review and discussions at medical, legal, and regulatory (MLR) review meetings. Support creating/updating SOPs, checklists, templates, style guides, and guidance documents as necessary. Work collaboratively with other cross-functional medical and scientific reviewers, medical writers, and creative teams across EVERSANA. All other duties as assigned. Responsible to deliver CLIENT DELIGHT. Responsible to work collaboratively with EVERSANA medical information and medical affairs teams and taking direction and feedback from management and clients. Responsible to ensure management and compliance with industry standards and codes of practice. Able to work independently to support the development of high-quality, scientifically accurate, strategically aligned, ethical, and compliant promotional and non-promotional content. Responsible for proactively flagging and managing any quality issues, and ensuring timely corrective and preventive actions. Travel - Up to 10%. Hou

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