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    Medical Affairs Manager

    Eversana
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company Description

    At EVERSANA, we are honored to be globally recognized as a Great Place to Work. Our mission is clear: we are driven by a vision to create a healthier world. With a dedicated team of more than 7,000 employees, we deliver next-generation commercialization services to the life sciences industry. We proudly support over 650 clients, from innovative biotech start-ups to established pharmaceutical companies, by providing cutting-edge solutions that bring therapies to market and improve the lives of the patients who rely on them.

    Our company thrives on the belief that diverse experiences and backgrounds are essential to our success. Improving patient outcomes globally is our priority, and we actively seek individuals from all walks of life to help shape the future of healthcare. We understand that our people are key to cultivating a culture of inclusion, where diverse perspectives are valued. At EVERSANA, we are intentional about building a team and culture that cares deeply about our people, our clients, and most importantly, the patients we serve.

    Job Description

    THE POSITION

    The Medical Affairs Manager plays a crucial role in the development and delivery of medical content, ensuring that all materials are scientifically accurate, compliant, and aligned with industry standards. This customer-facing position supports the safe and effective use of pharmaceutical, biopharmaceutical, medical devices, and digital therapeutics by providing timely, evidence-based, and non-promotional medical information. The role includes managing medical content development and the review of promotional and non-promotional materials, ensuring adherence to local and global regulations, including IFPMA, EFPIA, and other industry codes of practice.

    Key Responsibilities

    1. Medical Content Development

      • Support the Global Medical Information / Medical Content Development Team on client engagements for medical content development and management.
      • Develop project plans in collaboration with the project management team, ensuring timely and high-quality deliverables.
      • Coordinate and participate in meetings with clients, documenting agendas and action items.
      • Write and develop medical content and ensure quality assurance for assigned materials.
      • Manage medical content through document management platforms such as Veeva PromoMats / MedComms.

    2. Medical Review

      • Act as the responsible Final Medical Signatory for medical review of promotional and non-promotional materials across specific countries, ensuring compliance with local regulations.
      • Review and approve materials for scientific accuracy, ensuring all claims are substantiated with data and are in alignment with approved labels.
      • Participate in MLR (Medical, Legal, and Regulatory) review meetings and collaborate with other stakeholders to ensure the quality and regulatory compliance of the materials.
      • Address any issues impacting timelines and manage quality control processes.

    3. Client Collaboration and Compliance

      • Work closely with internal teams (Medical Affairs, Project Management, Medical Information) to ensure materials meet the client's needs and regulatory requirements.
      • Maintain detailed records for regulatory compliance, ensuring all activities adhere to industry standards.
      • Act proactively to identify and resolve any quality issues, ensuring corrective actions are implemented.

    4. Additional Responsibilities

      • Collaborate with EVERSANA’s internal teams to ensure the smooth delivery of client projects.
      • Travel requirements: Up to 10-15% travel may be required.
      • Flexible work schedule as required by clients and management.

    Qualifications

    Minimum Requirements:

    • Advanced degree in Life Sciences (PhD, MD, PharmD) or related field.
    • Minimum of 2 years of experience in Medical Affairs, Medical Information, or Medical Communications, including medical review of promotional and non-promotional materials.
    • Strong understanding of regulatory requirements for medical information and medical affairs, including IFPMA, EFPIA, ABPI codes.
    • Proven experience in medical content development and review, with a focus on scientific accuracy, compliance, and quality assurance.
    • Exceptional written and oral communication skills, with the ability to interpret and present complex scientific data.
    • Experience with document management and review platforms, such as Veeva, is preferred.

    Preferred Qualifications:

    • Experience with global medical content development, including scientific response documents (SRDs), frequently asked questions (FAQs), and custom response documents (CRDs).
    • Subject Matter Expertise (SME) in therapeutic areas relevant to the company’s portfolio.
    • Proficiency in additional languages (e.g., French, Spanish, Italian) is a plus.
    • Experience with project management, with a demonstrated ability to manage multiple projects and meet deadlines.

    Additional Information

    • Patient Minded: Always act with the patient’s best interests in mind.
    • Client Delight: Own every client experience and its impact on results.
    • Take Action: Empowered to hold yourself accountable.
    • Embrace Diversity: Create an environment of respect and awareness.
    • Grow Talent: Invest in your development and the development of others.
    • Win Together: Collaborate passionately to achieve results.
    • Communication Matters: Foster transparent, thoughtful, and timely dialogue.
    • Always Innovate: Approach everything with creativity and boldness.

    Equal Opportunity Employer: EVERSANA is committed to diversity, equity, and inclusion in the workplace. We welcome employees from diverse backgrounds and experiences, including race, gender identity, age, disability status, sexual orientation, religion, and veteran status. All perspectives are essential to our success.

    Workplace Integrity: EVERSANA values professionalism and ethical behavior. We encourage all candidates to be cautious of recruitment scams and ensure they only interact with verified EVERSANA sources throughout the hiring process.

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