Medical Affairs Manager, Germany

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 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. 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.  

At EVERSANA, our integrated compliance services team that includes Medical Affairs, Medical Information, Pharmacovigilance, Regulatory, and Quality provides support for biopharmaceutical, medical device, digital therapeutics, and other life sciences organizations around the world to support the delivery of therapies to patients, including innovate novel therapies for rare disease and specialty therapeutic areas including oncology, hematology, neurology, immunology, dermatology, nephrology, etc.

The Medical Affairs Manager will ensure 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 (e.g., IFPMA-Code of Practice, EFPIA-Code of Practice, AMG and HWG) while following ethical standards. They will also support content development-related client engagements.

The ideal candidate will have a strong background in medical review and would be registered as a final signatory in Germany be fluent in both English and local language (German), excellent communication skills, and a keen eye for detail. This position is within the EVERSANA Compliance service line and part of the Medical Information and Medical Content Development functions, reporting directly to the Associate Director, Global Medical Content and Medical Review and Director, Medical Information Strategic Operations (Europe). This position involves working in a matrix environment, collaborating closely with the leadership team.

ESSENTIAL DUTIES AND RESPONSIBILITIES: Our employees are tasked with delivering excellent business results through the efforts of their teams.

Medical Review Promotional / Non-Promotional Materials

• For assigned clients and products, act as a scientifically responsible person and Final Medical Signatory for Germany where promotional/non-promotional materials will be disseminated as per the relevant applicable codes (e.g., IFPMA and EFPIA Codes of practice in Germany.
• Contribute to the review and approval of country specific promotional and non-promotional materials in collaboration with client’s Medical Affairs colleagues for scientific accuracy and in compliance with International and Local regulations and guidelines, as well as client’s internal policies.
• Review promotional/non-promotional materials for content and accuracy; participate in review committee/strategic meetings to provide inputs on 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:
• • 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.
• Identify, communicate, and resolve issues impacting timelines.
• Work collaboratively within Medical, Legal, Regulatory (MLR) review committee meeting providing support and direction to material developers and owners.
• Submission of promotional materials to the regulatory authorities when applicable.
• Demonstrate and maintain thorough expertise and understanding of assigned products, therapeutic areas, applicable laws, regulations, guidance documents, industry standards, publication requirements and best practices regarding the review and approval of promotional and non-promotional materials.
• Participate in MLR committee and applicable client meetings.
• Experience working with review and approval systems (e.g. Veeva).

Medical Affairs Strategy and Support

• This position will primarily serve as a Subject Matter Expert (SME) for Medical Affairs and maintain knowledge of local and international industry standards, best practices, and applicable laws and regulations.
• Collaborate with the Head of Medical Content Development / Medical Affairs / Medical Information and contribute to discussions on strategy, tactical execution, and communication approaches for assigned projects.
• Oversee assigned client projects to ensure success (e.g., client manager/project lead for medical content

/ medical review), understand client needs, and act as a liaison with client stakeholders. Collaborate and provide direction to medical writers, graphic design team, etc. for projects assigned to manage.

• As applicable, participate in development, review, and maintenance of key medical affairs deliverables such as scientific narratives, advisory board presentations, scientific meeting materials, medical slide decks, medical information content, publications etc. Provide support for thought leadership and developing industry relations.
• 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.

•  Educational Background: The appointed IB (Information Beauftragter) has the “expertise and reliability required”. It must be proven that IB has the sufficient specialist knowledge. Minimum proof of qualification is a certificate of an examination passed after completing a university degree in pharmacy, biology, or medicine.
• Experience and/or Training
  • Minimum 2 years of experience as a Medical Reviewer/IB
• Language Proficiency: Fluency in German and English (both written and spoken) is required.
• Regulatory Knowledge: The IB Needs to have knowledge of the national case law; the Law on Advertising in the Health Sector (Heilmittelwerbegesetz – HWG), the Law on the Trade in Medicinal Products (Arzneimittelgesetz – AMG) and the Act against Unfair Competition (Gesetz gegen den unlauteren Wettbewerb – UWG).
• Analytical Skills: Strong analytical and problem-solving skills to evaluate promotional materials and ensure compliance.
• Communication Skills: Exceptional written, oral, interpersonal, and presentation skills including the ability to effectively interface with health authorities, internal teams, and external stakeholders.
• Ability to establish credibility with a variety of audiences.
• Demonstrated project and time management skills.
• Highly Principled – Proves to be a professional of unquestionable integrity, credibility and character who demonstrates high moral and ethical behavior.

PREFERRED QUALIFICATIONS:

• Experience and/or Training: 5+ years of experience as a Medical Reviewer of promotional and non- promotional materials. Prior experience in Medical Affairs / Medical Information / Medical Communications within Biotechnology or Pharmaceutical Industry.
• Preferred location: Germany
• Licenses/Certificates:    Licensed healthcare professional      (physician    or   pharmacist).                                          Additional certifications in Medical Affairs, Regulatory Affairs or Compliance are advantageous.
• 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 advancement 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.

EXPECTATIONS OF THE JOB:

• Responsible to deliver Client Delight.
• Uphold the highest standards of scientific integrity and ethical behavior.
• Responsible to work collaboratively with EVERSANA medical information and medical affairs teams and take direction and feedback from EVERSANA management and clients.
• Maintain detailed and organized records to ensure regulatory compliance. Responsible to ensure management and compliance with industry standards and codes of practice.
• Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical medical content.
• Responsible to proactively flag and manage any quality issues and ensure timely corrective and preventive actions are implemented.
• Maintain detailed and organized records to ensure regulatory compliance.
• Collaborate effectively with cross-functional teams.
• Stay informed about the latest developments in pharmaceutical regulations and industry standards.
• Travel: In general, this position does not travel; however, the incumbent will need to be able to travel up to 10%.
• Hours: Able to work full-time and be flexible with work scheduling as required by clients and management. (40 Hours per week, 5 days of the week).

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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