Manager, Medical Affairs and Scientific Review

Company Description

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. How? 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 are grounded in our cultural beliefs and serve more than 670 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. Our jobs, skills and talents are unique, but together we make an impact every day. Join us!

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA.

Job Description

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, women’s health, and more.

This position is part of our Global Medical Content Development and Medical/Scientific Review team. The role requires strong medical and scientific expertise, a solid understanding of regulatory requirements and the best industry practices for both promotional and non-promotional materials in accordance with European pharmaceutical regulatory requirements, codes, and guidelines, including EMA regulations and guidance, the EFPIA Code, the ABPI Code of Practice, and country-specific regulations governing promotional and non-promotional communications. Candidates must demonstrate exceptional attention to detail, a commitment to medical and scientific accuracy, and the ability to critically analyze, interpret, and translate scientific literature and data into clear, compliant content. The ideal candidate will be able to rapidly develop expertise in new therapeutic areas and possess excellent written and verbal communication skills. This is a full-time, home-based position, and applicants must be legally authorized to work in Europe and hold a valid work permit.

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 REVIEW

• Lead the medical and scientific review of promotional and non-promotional materials for assigned products and markets, ensuring compliance with applicable regulations, industry codes (e.g., EFPIA, ABPI), and internal policies.
• Serve as the scientific reviewer and subject matter expert (SME) for assigned therapeutic areas and products, providing strategic medical input throughout content development and review
• Ensure that data are scientifically accurate, contextually correct, editorially accurate, and are presented in a fair/scientifically balanced manner with minimal supervision and on time:
  • 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
  • Ensures that the piece is relevant and of utility for the target audience.
• Collaborate with Medical Affairs, Legal, Regulatory, Commercial, and cross-functional teams of reviewers and writers to facilitate compliant and effective scientific communications
• Participate in Medical, Legal, and Regulatory (MLR) review committees, providing guidance on scientific substantiation, messaging, and risk mitigation
• Review and approve country-specific materials, ensuring alignment with local and international regulations, guidance documents, and client requirements.
• Contribute to the development and review of key Medical Affairs deliverables, including scientific narratives, medical presentations, publications, meeting materials, and medical information content.
• Maintain expertise in therapeutic areas, industry standards, regulatory requirements, publication practices, and review platforms (e.g., Veeva) to drive continuous quality and compliance
• Support regulatory submissions of promotional materials and associated documentation, where required by local authorities.

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 a 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 writing and developing materials, in addition to performing quality assurance of assigned writers’ and graphic designers' deliverables
• Works with EVERSANA and/or client-provided document management technology platforms (i.e., Veeva PromoMats / MedComms, etc.) as content owner and attending MLR meetings when appropriate
• If assigned, may attend cross-functional team meetings (e.g., complete commercialization meetings)
• All other duties as assigned

GENERAL

• Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias
• All other duties as assigned.

EXPECTATIONS OF THE JOB:

• Responsible for delivering CLIENT DELIGHT
• Responsible for working collaboratively with the EVERSANA medical information and medical affairs team and taking directions and feedback from management and clients
• Responsible for ensuring management and compliance with industry standards and codes of practice
• Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical, and compliant medical content
• Responsible for proactively flagging and managing any quality issues, and ensuring timely corrective and preventive actions
• Hours: Able to work full time and be flexible with work scheduling as required by clients and management

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

• Education: Advanced degree in Medicine, Pharmacy, or a related healthcare discipline.
• Experience and/or Training: Minimum 2 years of experience reviewing promotional and non-promotional materials for scientific accuracy, regulatory compliance, and adherence to industry standards.
• Language Proficiency: Fluency in English (written and spoken) is required. Additional European language(s) may be required based on market responsibilities and are a plus
• Regulatory Knowledge: Strong understanding of pharmaceutical regulations, industry codes, and compliance requirements governing promotional and non-promotional communications within Europe. Knowledge of EMA regulations and guidance, the EFPIA Code, the ABPI Code of Practice, and relevant country-specific laws, regulations, and industry codes.
• Familiarity with requirements governing interactions with healthcare professionals, healthcare organizations, patients, and patient organizations
• Strong analytical, critical-thinking, and problem-solving skills with the ability to evaluate scientific literature, clinical data, and promotional claims for medical accuracy and regulatory compliance
• Exceptional written, verbal, interpersonal, and presentation skills, including the ability to communicate complex scientific information clearly and effectively.
• Ability to effectively collaborate with cross-functional teams, health authorities, clients, and external stakeholders.
• Ability to establish credibility with a variety of internal and external audiences.
• Demonstrated project management, organizational, and time-management skills, with the ability to manage multiple priorities in a fast-paced environment.
• High attention to detail and commitment to scientific excellence and compliance.
• Demonstrates the highest standards of professionalism, integrity, ethical conduct, and sound judgment.

PREFERRED QUALIFICATIONS:

• Education: Candidates with a Pharm.D., Pharm.M., or Medical Degree are strongly preferred.
• Experience and/or Training: Over 5 years of experience reviewing promotional and non-promotional medical materials, with expertise in developing global Medical Information content, including Scientific Response Documents (SRDs), Frequently Asked Questions (FAQs), and Custom Response Documents (CRDs)
• Licenses/Certificates: ABPI Final Signatory certification/status or demonstrated capability to complete company-approved Final Signatory training and ABPI assessment.
• Technology/Equipment: Experience with Medical Affairs / Medical Information and Medical Review systems (Veeva Vault PromoMats/ MedComms), digital solutions, AI.
• Passion for innovation and well-versed with the technological advancements across, including advanced data analytics, application of automation and AI, etc.
• Professional Development: Commitment to continuous professional development and staying current with industry trends and regulatory changes

Additional Information

OUR CULTURAL BELIEFS 

• Patient Minded I act with the patient’s best interest in mind. 
• Client Delight I own every client experience and its impact on results. 
• Take Action I am empowered and hold myself accountable.  
• Embrace Diversity I create an environment of awareness and respect.  
• Grow Talent I own my development and invest in the development of others.   
• Win Together I passionately connect with anyone, anywhere, anytime to achieve results.  
• Communication Matters I speak up to create transparent, thoughtful, and timely dialogue. 
• Always Innovate I am bold and creative in everything I do. 

Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

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. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility.

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