Sr Medical Affairs Associate

Fresenius Kabi • Lake Zurich, IL

1d • $130,000 - $140,000 • Onsite

About The Position

The Senior Medical Affairs Associate position will divide time between Medical Information/Medical Review responsibilities and other Medical Affairs key initiatives including but not limited to evidence generation, medical education/communication, advisory/consulting activities, and operational activities/improvements. This individual will serve as the operational lead responsible for creating and managing the dissemination of medical information. Conduct interdepartmental training on product education and product complaint handling procedures. Lead and mentor the Medical Affairs staff and provide peer review for departmental processes. Provide scientifically balanced medical information on products to external (physicians, pharmacists, nurses, and other health care professionals) and internal customers. Represent US Medical on cross-functional teams, providing high quality deliverables for approved products in preparation for launch and for lifecycle management. This position requires working onsite 3 days per week at our Lake Zurich, IL U.S. headquarters.

Requirements

• Bachelor’s degree required.
• Medical/clinical professional degree required e.g., PharmD, RPh, RN degree.
• 5+ years of experience.
• 3+ years of medical information/communications experience in the pharmaceutical industry required.
• Leadership, training, and/or mentoring experience required.
• Ability to understand and interpret federal regulations and company operating procedures to determine whether the event constitutes a potential product quality issue.
• Ability to critically evaluate the published medical and scientific literature and approve and/or write and update comprehensive, medically accurate and scientifically fair-balanced standard response documents for response to medical information inquiries from healthcare providers.
• Knowledge of PC systems and Microsoft Office Suite (Word, Excel) required.

Nice To Haves

• Experience in a hospital setting preferred.

Responsibilities

• Work with stakeholders to develop and/or support execution of key Medical Affairs initiatives to support the business/division including but not limited to evidence generation (publications, clinical studies), medical education/communication, advisory/consulting activities, operational initiatives, new product assessment and regulatory requests.
• Serve as operational lead for creating, reviewing, tracking and managing medical information of the highest quality, including Standard Response letters and fulfillment of ad hoc requests.
• Mentor and train Medical Affairs staff.
• Conduct interdepartmental training/education on key products and medical inquiry and product complaint handling procedures and databases.
• Responsible for peer review of medical information requests.
• Research and respond to unsolicited requests for medical information from health care professionals regarding the company's marketed products (clinical and technical).
• Maintain an in-depth understanding of product knowledge, labeling, and relevant data for company products and maintain current awareness for the published literature.
• Review product labeling changes.
• Serve as a medical expert and act as a medical information liaison on company marketed products for internal stakeholders providing high quality deliverables and input based on scientific rigor.
• Responsible for review of promotional material for medical accuracy and fair balance (benefits vs. risks) as part of the Medical Regulatory Legal (MRL) review team.
• Interact with the Quality and Regulatory Departments to resolve medical, safety and quality issues.
• Provide product support during afterhours (on-call).
• Knowledgeable of all pertinent medical information publications, requirements, and guidelines on medical communications/information.

Benefits

• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.
• We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees