Job Description

Job Summary

The Medical Affairs Associate is responsible for creating and managing the dissemination of medical information. Provide scientifically balanced medical information on products to external (physicians, pharmacists, nurses, and other health care professionals) and internal customers. Work on cross-functional teams to provide high quality deliverables for approved products and products in development.

This position will also serve as an additional resource as a Quality Complaint Specialist. Responsible for intake of and obtaining follow-up information for product quality complaints. This position impacts all product quality complaints, which plays a role in ensuring the facility's GMP/FDA compliance status. It is essential that duties are performed promptly and accurately with special attention to each incident as the product's safety, quality, identity, purity and potency could be impacted.

*This position requires working on-site at our Lake Zurich, IL site 3 days per week; the other days may be worked remotely.
*This position does not offer visa sponsorship either now or in the future.
• Salary Range: $100,000-120,000
• Position is eligible to participate in an annual bonus plan with a target of 6% of the base salary.
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• 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.

Responsibilities

• Create, review, track and manage clear and concise medical information of the highest quality, including Standard Response letters and fulfillment of ad hoc requests.
• Research and respond to unsolicited requests for medical information from health care professionals regarding the company's marketed products (clinical and technical).
• Review product labeling changes.
• Responsible for review and approval of parenteral nutrition promotional material for accuracy and fair balance (benefits vs. risks) as part of the Medical Regulatory Legal (MRL) review team in the Veeva electronic review system.
• Serve as a medical nutrition expert and act as a liaison with Global Production, Market Units, and Innovation and Development for medical information on company marketed parenteral nutrition products, as well as products in development providing high quality deliverables or due diligence materials for business related needs.
• Responsible for review and approval of Medical Affairs IRMS case processing.
• Attendance and Medical Affairs booth coverage at National Conferences.
• Receive, process, peer review and contribute to the investigation of product quality complaints.
• Provide product support during afterhours (on-call).
• Conduct intake of product quality complaints and ensures that quality complaints are addressed promptly and handled accurately in accordance with SOPs and quality agreements.

Job Requirements:

• Medical/clinical professional bachelor's degree required (i.e., PharmD, RPh, RN degree, RD). Master's degree preferred.
• 3+ years' clinical experience required.
• Medical information/communications experience preferred.
• Experience in a hospital setting with knowledge of parenteral nutrition preferred.
• 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 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 (Outlook, Word, Excel) preferred.
• Position will include 10-20% travel to professional conferences.

Additional Information

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.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Job Tags

Full time, Work at office, Remote work, 3 days per week,

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