Medical Affairs Manager

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Improving patient lives around the world is a priority, and we need people from all backgrounds to help build the future of healthcare and the life sciences industry.

THE POSITION:

Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical, biopharmaceutical, medical device, and digital therapeutic products by providing timely, scientifically balanced, evidence-based, non-promotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and payers.

An important aspect of medical information is developing, managing, and providing impactful medical response documents. The Medical Affairs Manager is responsible for medical content development-related client engagements and ensuring the accuracy, quality, and compliance of the medical review of promotional and non-promotional materials adhering to local regulations, legislation, European regulatory standards, and best practices while following ethical standards. This role requires excellent communication skills (both verbal and written).

Essential Duties And Responsibilities

• Medical Content Development

• Plays an essential role in supporting the Global Medical Information / Medical Content Development Team on content development-related engagements for clients who require medical content development and management services.
• Establishing project plan (in partnership with project management when applicable).
• Accountable for the client deliverables, including timeliness and quality.
• Coordinating and participating in meetings with clients, agendas, action items, follow-up.
• Responsible for providing direction, coordinating, communicating, and working with assigned writers, graphic designers, project management.
• Responsible for writing and developing materials, in addition to performing quality assurance of assigned writer’s and graphic designers' deliverables.
• Works with EVERSANA and/or client-provided document management technology platforms as content owner and attending MLR meetings when appropriate.
• If assigned, may attend cross-functional team meetings.
• All other duties as assigned.

• For assigned clients and products, act as a scientifically responsible person and Final Medical Signatory medical reviewer for Germany, Spain, Italy, France, or the UK where promotional/non-promotional materials will be disseminated as per the relevant applicable codes.
• Contribute to the review and approval of country-specific promotional and non-promotional materials in collaboration with the client’s Medical Affairs colleagues for scientific accuracy and in compliance with International and Local regulations and guidelines, as well as the client’s internal policies.
• Review promotional/non-promotional materials for content and accuracy; participate in review committee/strategic meetings to provide inputs on the product, therapy area, reference substantiation, alignment to brand messages, etc.; review and approve data on file packets; and manage planning and prioritization of reviews.
• 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.
• Identify, communicate, and resolve issues impacting timelines.
• May work collaboratively within Medical, Legal, and Regulatory (MLR) review committee meetings providing support and direction to material developers and owners.
• May submit promotional materials to the regulatory authorities when applicable.

Qualifications

• Education: Pharmacy, Medical Doctor, or PhD degree in Life Sciences or healthcare or equivalent.
• Experience and/or Training: A minimum of 2 years experience in the pharmaceutical industry or Medical Information / Medical Communications service provider and medical review experience.
• Strong understanding of regulatory requirements and best practices in relationship to Medical Information, Medical Affairs, and promotional and non-promotional materials review.
• Exceptional written, oral, interpersonal, and presentation skills including the ability to independently interpret and summarise complex results.
• Proficient editing skills along with expertise in Microsoft Office, Acrobat, and other applications.
• Experience in review and approval platforms.

This position may require business travel and will need to be able to travel up to approximately 10-15%. Able to work full-time and be flexible with work scheduling as required by clients and management.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry.