Commercial Operations Specialist

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!

 

Summary:

The Commercial Operations Specialist is responsible for specific Commercial Operations support including managing end-to-end process of promotional material inventory, fulfillment, and compliance, FDA 2253 submissions and field operations day to day support. The specialist manages promotional material inventory and distribution through our warehouse vendor and supports both field and home office personnel through streamlined ordering systems, tracking, and reporting.  Additionally, in partnership with Regulatory Affairs, Promotional Review Committees (PRC/MLR), and Marketing, this role ensures timely and accurate submission of promotional materials to the FDA’s Office of Prescription Drug Promotion (OPDP). The specialist will also coordinate onboarding and offboarding of sales representatives as it relates to support of speaker programs, fleet and sampling activities.

 Essential Functions:

Inventory Management 

• Confirm shipments of inventory, quantities and accuracy of Advance Stock Notification Forms and reconcile discrepancies with Lundbeck and Lundbeck 3rd parties as necessary
• Manage custom assembly and kitting requirements with the fulfillment warehouse as applicable
• Coordinate with commercial team and warehouse to ensure timely shipment of materials to Lundbeck sales force based on pre-determined timelines
• Proactively provide inventory reports and metrics to aid in compliance of promotional materials
• Collaborate with Lundbeck commercial teams regarding inventory on monthly basis to ensure appropriate amount of orderable materials and destruction/discontinuation as necessary
• Coordinate large shipments to conventions and sales meetings
• Manage and update as necessary the online ordering tool for home office and field personnel
• Train new sales force employees on use of the online order tool
• Monitor fulfilment and warehousing spend to ensure budget efficiencies

2253 Submission Management

• Prepare and submit FDA Form 2253 with final promotional materials, ensuring accuracy and compliance
• Maintain submission records, reference numbers, and archives per internal SOPs and regulatory requirements.
• Ensure monthly Social Media reports are reviewed, updated and submitted to FDA in timely manner
   

Onboarding/Offboarding sales force

• Coordinate the setup and delivery of a fleet vehicle or rental, including working with third-party vendors to arrange vehicle logistics and secure a sample storage unit, if applicable.
• Partner with vendors to provide access to systems needed to support sampling, speaker program and fleet activities.
• Schedule vehicle retrievals through third-party vendors when needed.
• Assist with the transferring and delivering of samples once product certification is complete, if applicable.
• Manage the return or transfer of company samples, and work with Compliance Operations Compliance Manager to escalate and report any instances of non-compliance or lack of response
   

 Required Education, Experience, and Skills:

• Accredited bachelor’s degree
• 2 years of experience in Biotech, Medical Device or Pharmaceutical regulatory operations, regulatory affairs, marketing operations, or promotional review (PRC/MLR)
• Familiarity with pharmaceutical promotional materials, labeling, and compliance requirements.
• Basic understanding of inventory processes and comfort learning to use online ordering systems, databases, and simple reporting tools.
• Attention to detail and problem-solving skills
• Strong verbal and written communication skills
   

Preferred Education, Experience, and Skills:

• Experience with supporting operational needs (sampling, fleet, speaker programs) of a nationally dispersed field sales force
• Skilled in managing timelines, vendors, and cross-functional collaboration.
• Proficient in generating and interpreting inventory reports and metrics.  
• Experience coordinating shipments, kitting, and warehousing logistics.
• Experience with FDA Form 2253 submissions or demonstra