Job Information
Actalent Medical Affairs Associate in Lake Zurich, Illinois
Job Title: Medical Affairs AssociateJob Description
Responsible for creating and managing the dissemination of medical information. Provide scientifically balanced medical information on products to external (physicians, pharmacists, nurses, and other healthcare 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.
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 healthcare professionals regarding the company's marketed products (clinical and technical).
Maintain an in-depth understanding of product knowledge, labeling, and relevant data for company nutrition products and maintain current awareness of the published literature.
Review product labeling changes.
Review and approve 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.
Provide technical and subject matter expertise for the Information Request Management System (IRMS) database.
Review and approve Medical Affairs IRMS case processing.
Contribute to/support the development of educational materials and presentations to support internal and external medical and scientific exchange related to company products and increase knowledge of PN portfolio.
Attend and provide 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).
Maintain knowledge of all pertinent medical information publications, requirements, and guidelines on medical communications/information.
Interact with the Quality and Regulatory Departments to resolve safety and quality issues.
Maintain a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
Conduct intake of product quality complaints and ensure that quality complaints are addressed promptly and handled accurately in accordance with SOPs and quality agreements.
Ensure compliance with cGMP, SOP, and FDA regulations.
All employees are responsible for ensuring compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, as per their roles and responsibilities.
Essential Skills
Clinical Nutrition
Parenteral Nutrition
Pharmacist
Registered Dietician
Medical Affairs
Medical Information
Pharmaceutical
FDA
GCP
Regulatory
Additional Skills & Qualifications
MS and Registered Dietician OR PharmD and Registered Pharmacist
2+ years of clinical nutrition or parenteral nutrition experience in a hospital or home-health setting (infusion)
Pharma industry experience in medical information or medical affairs is nice to have.
Work Environment
Hybrid work environment with 3 days on-site (Wednesday is required) and 2 days working from home.
Pay and Benefits
The pay range for this position is $40.00 - $65.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Lake Zurich,IL.
Application Deadline
This position is anticipated to close on Mar 28, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.