EVERSANA is a leading independent provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 670 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world.
Post : Medical Information Specialist, Medical Reviewer, Medical Content and Review Specialist
Medical Information Specialist
Job Description
Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical company products by providing timely, scientifically balanced, evidence based, non-promotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and payers. Medical Information also plays an important role in post-marketing handling of adverse events and product complaints. As part of the Medical Information Contact Center (MICC) team, this position delivers industry-leading services, which include Contact Center staffing for responding to product information requests, identifying and handling of adverse events and/or product quality issues, and medical writing as needed to generate written response for use in response to medical questions received. This position requires clinical and therapeutic knowledge, critical and analytical thinking, and customer/patient-centric approach. Medical Information Specialists typically support multiple pharmaceutical clients, multiple products, and multiple therapeutic areas.
Essential Duties and Responsibilities :
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by :
• Respond to medical information inquiries from physicians, pharmacists, nurses, and other health care professionals, consumers, and payers. Utilize medical information skills to identify, research, and critically evaluate medical literature to create responses to medical information inquiries.
• Utilize writing skills for adverse event and product complaint narrative during intake as well as medical inquiry custom responses.
• Handle requests across multiple channels and platforms (phone, email, CRM, chat, etc.)
• Identify adverse events and product complaints during interactions with customers. Perform intake sufficient to generate adverse event and product complaint reports in compliance with EVERSANA-MICC and client standard operating procedures. Knowledge of FDA’s post-marketing adverse event reporting regulations and safety terminology. Ability to make accurate assessments regarding what information needs to be obtained and level or depth of information to be collected.
• Coordinate processes necessary for responding to product quality-related complaints. This process may involve interactions with personnel in the following departments: Quality Assurance, Regulatory Affairs, and the complainant.
• Maintain product, therapeutic area, and client specific requirements knowledge.
• Ensure good documentation, high quality, and excellent customer service.
• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.
All other duties as assigned
Minimum knowledge, skills and abilities :
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
• Experience and/or Training Excellent documentation skills, excellent verbal and written communication skills, and strong clinical background.
• Must speak, read, and write in English fluently.
Qualifications
• Education Pharm.D, Master of Science (Msc), B.Pharm, M.Pharm, or any other Life Sciences degree.
• Experience and/or Training Excellent documentation skills, excellent verbal and written communication skills, and strong clinical background.
• Must speak, read, and write in English fluently.
Medical and Scientific Reviewer
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:
o Ensures scientific accuracy, relevance, and completeness of data
o Ensures claims and data are clinically and statistically relevant and presented in a scientifically balanced manner (not false or misleading)
o Ensures that claims are adequately supported by data
o Determines acceptability of references
o Advises on whether claims are consistent with the approved label
o 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%.
• Hours – Average 40+ hours/week
Qualifications
The requirements listed below are representative of the experience, education, knowledge, skill, and/or abilities required.
• PharmD (or M. Pharm. or M.S. Pharm), Ph.D., BDS, MDS, or MBBS with relevant experience in scientific writing and/or reviewing.
• Minimum of 2 years of experience in document QC and/or scientific writing within the life science and/or pharmaceutical industry.
• Experience conducting literature searches and analysis and working with tools such as RightFind, PubMed, Ovid, Embase, etc.
• Strong scientific and medical acumen and ability to grasp complex therapeutic areas (e.g., rare diseases, immunology, oncology / hematology, gene therapy).
• Understanding of medical terminology, clinical trials, and drug development process.
• Ability to analyze and interpret scientific and medical data and translate it for different audiences (e.g., HCPs, payers, patients / caregivers).
• Highly detailed orientated and excellent time management skills.
• Exceptional communication skills including, written, oral, interpersonal, and presentation skills including the ability to independently interpret and summarize complex results.
• Experience using content development and management tools and review / approval platforms (e.g., Veeva Vault PromoMats / MedComms).
• Ability to effectively interface with all levels of management and staff and to succeed in a matrix team setting while meeting or exceeding timelines.
• Proficient editing skills along with expertise in Microsoft Office, Acrobat, and other applications.
• Strong understanding of regulatory requirements and best practices concerning Medical Information, Medical Affairs, and promotional and non-promotional materials review.
• Excellent project management skills and proven track record of being results-driven; ability to manage.
• Highly Principled - Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior.
• Collaboration – Ability to work cross-functionally across EVERSANA business units and with various clients, including leadership and various departments and functions of our clients.
• Agile learning – Ability to support and learn about multiple disease states and therapeutic areas.
Medical Content and Review Specialist
Job Description
The Position :
The Medical, Legal and Regulatory (MLR) review is an essential process in healthcare marketing to make sure advertising, promotional and non-promotional content is accurate, compliant, and ready to be published. The MLR process must rigorously control and execute review, approval and document filing actions. As part of the MLR team, the Medical Content and Review Specialist is responsible for managing all the MLR process for a dedicated client. The Medical Content and Review Specialist ensures that all administrative and program management support for the client’s MLR process operates effectively and in full compliance with all internal and external policies and regulations.
Essential Duties and Responsibilities :
Our employees are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by :
Medical Content and Review Specialist Responsibilities
• Manages the end-to-end MLR process.
• Responsible for scheduling, setting the agenda, and leading Review Committee meetings.
• Add live discussion notes for comments discussed in Veeva Vault
• Scribe meeting minutes, circulate draft meeting minutes for Committee approval and finalize and file approved minutes
• Ensure all covered communications are properly vetted through the review process utilizing the online review system (e.g., Veeva Vault PromoMats and Vault MedComms)
• Cascade and enforce any new policies and guidelines related to review of materials.
• Verifies that materials are assigned to the appropriate review path
• Rejects incomplete submissions and materials that are not review ready
• Facilitates/documents discussion in live meetings.
• QCs Final Document vs. Approved Document
• Supports FDA 2253 submissions with MLR Regulatory Reviewer/Partner
Medical Content Support Responsibilities
• Support the development of project plans
• Support medical content development team
• Support upload of materials into clients’ review and approval platforms, including supporting annotating, anchoring references, etc.
Medical Affairs and Medical Information Project Management Support
• Support Medical Affairs and Medical Information leadership in developing and managing project plans for key initiatives
All other duties as assigned.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Qualifications
• Education (i.e., degree required): Graduates in any Life Sciences / Biomedical field.
• Must demonstrate excellent ability to communicate effectively in English, both orally and in writing.
• Experience and/or Training:
• At least 2 years of experience in a healthcare agency or pharmaceutical company
• Experience with use of Veeva Vault PromoMats / MedComms
• Experience in Scientific Writing / Scientific Reviewing / MLR
• Project management
• Time management
• Meeting management
• Excellent customer service skills.
• Technology/Equipment: Computer proficiency in Outlook and Microsoft Office Suite (Word, Excel, PowerPoint, and other Window applications).
Additional Information
Qualification : B.Pharm, M.Pharm, Pharm.D, Msc, Lifesciences, Ph.D., MBBS, MDS, or BDS, Biomedical graduate
Location : Pune / Remote
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th June 2025
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