Senior Manager Medical Review Medical Information - Remote Opportunity

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

 

Remote Opportunity - open to candidates anywhere in the greater United States

 

SUMMARY:

The Sr. Manager of Medical Information and Medical Review is accountable for advancing Medical Information capabilities to meet the demands of customers and for leading the creation and maintenance of innovative medical assets and resources. The position will deliver strong medical and scientific subject matter expertise during promotional and non-promotional medical review. Additionally, this position will contribute through execution of accurate and relevant scientific content in response to MI requests, applicable training and development for internal partners and vendors, as well a support compliance requirements. The Sr. Manager will provide strong collaboration across multiple stakeholders to support business needs.

 

ESSENTIAL FUNCTIONS:

• Accountable for orchestrating the development of medical information resources and support content development. This includes maintenance, periodic updates, time-sensitive and urgent business needs. 
• Drive the analysis of customer interactions and identify actionable insights to inform medical strategy. 
• Provide guidance and direction to the Medical Information Call Center staff on handling routine and complex cases; monitor and manage complex escalated cases from the Medical Information Contact Center. 
• Perform and collaborate with regulatory and legal affairs as part of the MLR review and approval process for medical product and disease centered assets ensuring materials are scientifically accurate, appropriate to audience and aligned with strategy.
• Identifies and contributes to process improvement projects driving changes and updates to elevate medical information.
• Collaborates with business partners including field medical, medical strategy, commercial and external stakeholders to support informational needs, strategy and identifies opportunities for process improvements.

 

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

• Accredited Advanced scientific degree (i.e. Master's Science, Pharm.D., Ph.D, MD, etc.)  
• 3-5 years of combined medical review experience within Medical Affairs or Regulatory Affairs and medical information experience in the pharmaceutical, biotech, or healthcare industry or in an agency supporting these industries.   
• Demonstrate a working knowledge of US regulatory guidelines including FDA product promotional guidance, PHRMA Guidance and OIG, Guidance for pharmaceutical manufacturers. 
• Ability to critically evaluate medical literature and fact check materials against source documents and show highest level of accuracy in attention to smallest details. 
• Highly developed project management abilities; capable of effectively coordinating multiple tasks while seeing projects to completion. 

 

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

• 2+ years of medical information experience in the pharmaceutical, biotech, or healthcare industry or in an agency supporting these industries.   
• 3+ years of Medical Review experience with Medical Affairs or Regulatory Affairs in the pharmaceutical, biotech or medical device industry or at an agency supporting these industries.   
• Experience in bioinformatics or Drug Informatics 
• Ability to perform complete literature searches for fulfillment of medical information inquiries 
• Ability to critically evaluate, contextualize and synthesize the medical literature 

 

TRAVEL:

• Willingness/Ability to travel up to 15% domestically. International travel may be required. 

 

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies and proficiency for the role. Salary Pay Range: