Develop strategy and tactics for an integrated Medical Plan (Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned rheumatology products.
Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables.
Communicate the details and progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution.
Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives.
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans.
Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners.
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of rheumatology products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities.
Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development.
Pro-actively provide guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams.
Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, and manage MSL resources and budgets.
Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the MSL budget.
Collaborate with the health economics team to address questions and opportunities.
Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations.
Review and approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials.
Provide medical review of applications for independent medical education grants.
Provide medical review of training materials for medical and commercial employees.
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR).
Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines, and accurate and timely reporting of study data.
Oversee conduct of all clinical studies in adherence to both Company standards and government/industry regulations (GCP/ICH).

Requirements

Minimum 5 years of relevant experience in Medical Affairs
Strong track record in developing and executing medical strategies in the US
Clinical or medical affairs experience in Rheumatology and/or Immunology strongly preferred
Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities
High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies
Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
In-depth understanding of how to conceptualize, design, and conduct clinical trials
Experience in clinical trial design and execution preferred

Benefits

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial designclinical trial executionmedical strategy developmentbudget managementdata analysismedical reviewscientific content approvalregulatory compliancehealth economicsmedical engagement planning

Soft Skills

communicationcollaborationleadershipstrategic thinkingteamworkproblem-solvinginterpersonal skillsorganizational skillsjudgmentinsight generation