No longer accepting applications (expired, filled, etc.)
Fresenius Kabi USA
Senior Manager, Medical Affairs
The Senior Manager, Medical Affairs leads and mentors the Medical Affairs Parenteral Nutrition staff, managing the creation and dissemination of clinical nutrition medical information. This role includes overseeing departmental processes related to clinical nutrition medical inquiries and conducting training for clinical nutrition products.
Key Responsibilities
- • Serve as the internal subject matter expert for parenteral nutrition products, providing scientific and technical expertise across cross-functional teams, including R&D, regulatory affairs, marketing, and medical affairs.
- • Provide regular project updates to internal stakeholders, highlighting progress, identifying key risks, and addressing any scientific, technical, or operational gaps.
- • Oversee and maintain detailed tracking of pipeline project activities, including stability and compatibility studies, both during development and post-commercialization phases.
- • Collaborate closely with internal partners to ensure data integrity, regulatory compliance, and scientific rigor in all aspects of product development.
- • Collaborate with the Parenteral Nutrition Medical Affairs team, and Medical Science Liaisons in the field.
- • Collaborate with Global & US Project Management, Regulatory Affairs and Commercial Team to obtain FDA approval of company products.
- • Prepare educational materials and presentations to support internal and external training efforts related to clinical nutrition products, medical inquiry procedures and databases for the clinical nutrition product line.
Required
- • Medical/clinical professional bachelor’s degree required (i.e., dietitian, pharmacist, nurse, physician) with advanced degree preferred (e.g., Pharm.D., MD, MS, APNP).
- • 8+ years’ clinical experience required.
- • 3+ years of medical information/communications experience in the pharmaceutical industry required.
- • 3+ years’ experience in a leadership/management role.
- • 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.
- • Position will include 10-20% travel for attendance at professional meetings.
- • Must be able to prioritize and multi-task with minimal supervision and participate in peer-review process when processing medical inquiries and product complaints.
Preferred
- • Nutrition support credential preferred (CNSC, CNSD or BCNSP).
- • Knowledge of PC systems and Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) and Endnote preferred.
Benefits & Perks
- • 401(k) plan with company contributions
- • paid vacation
- • holiday and personal days
- • employee assistance program
- • health benefits to include medical, prescription drug, dental and vision coverage
- • life insurance
- • disability
- • wellness program
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
Series B
Raised $50M Series B funding - Jan 2024
Award
Named "Best Healthcare Startup" by TechCrunch - Dec 2023
Growth
Expanded to 5 new states - Nov 2023
Job Summary
The Senior Manager, Medical Affairs leads and mentors the Medical Affairs Parenteral Nutrition staff. Responsible for leading and managing the creation and dissemination of clinical nutrition medical information in accordance with applicable regulations. Responsible for departmental processes related to clinical nutrition medical inquiries. Responsible for educating and assisting in the coordination of complaint review regarding the safety, efficacy, and quality for clinical nutrition products. Conducts interdepartmental training and product education for clinical nutrition products.
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.
The Senior Manager, Medical Affairs leads and mentors the Medical Affairs Parenteral Nutrition staff. Responsible for leading and managing the creation and dissemination of clinical nutrition medical information in accordance with applicable regulations. Responsible for departmental processes related to clinical nutrition medical inquiries. Responsible for educating and assisting in the coordination of complaint review regarding the safety, efficacy, and quality for clinical nutrition products. Conducts interdepartmental training and product education for clinical nutrition products.
- 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: $135,000-160,000
- Position is eligible to participate in an annual bonus plan with a target of 14% 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.
- Serve as the internal subject matter expert for parenteral nutrition products, providing scientific and technical expertise across cross-functional teams, including R&D, regulatory affairs, marketing, and medical affairs.
- Provide regular project updates to internal stakeholders, highlighting progress, identifying key risks, and addressing any scientific, technical, or operational gaps.
- Oversee and maintain detailed tracking of pipeline project activities, including stability and compatibility studies, both during development and post-commercialization phases.
- Collaborate closely with internal partners to ensure data integrity, regulatory compliance, and scientific rigor in all aspects of product development.
- Collaborate with the Parenteral Nutrition Medical Affairs team, and Medical Science Liaisons in the field.
- Collaborate with Global & US Project Management, Regulatory Affairs and Commercial Team to obtain FDA approval of company products.
- Prepare educational materials and presentations to support internal and external training efforts related to clinical nutrition products, medical inquiry procedures and databases for the clinical nutrition product line.
- Medical/clinical professional bachelor’s degree required (i.e., dietitian, pharmacist, nurse, physician) with advanced degree preferred (e.g., Pharm.D., MD, MS, APNP).
- Nutrition support credential preferred (CNSC, CNSD or BCNSP).
- 8+ years’ clinical experience required.
- 3+ years of medical information/communications experience in the pharmaceutical industry required.
- 3+ years’ experience in a leadership/management role.
- 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, PowerPoint) and Endnote preferred.
- Position will include 10-20% travel for attendance at professional meetings.
- Must be able to prioritize and multi-task with minimal supervision and participate in peer-review process when processing medical inquiries and product complaints.
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.
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