Commercial Operations Specialist jobs in United States
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Lundbeck · 2 weeks ago

Commercial Operations Specialist

Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. The Commercial Operations Specialist is responsible for managing promotional material inventory, compliance submissions to the FDA, and supporting field operations. This role also involves coordinating onboarding and offboarding of sales representatives and ensuring efficient inventory management.

Health CareHealth DiagnosticsMedical
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H1B Sponsor Likelynote
Hiring Manager
Laurie Meninno
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Responsibilities

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
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
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

Qualification

Biotech experienceRegulatory operationsPromotional reviewInventory managementFDA Form 2253Vendor managementCommunication skillsProblem-solving skills

Required

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

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 demonstrated understanding of the process

Benefits

Flexible paid time off (PTO)
Health benefits to include Medical, Dental and Vision
Company match 401k

Company

Lundbeck

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Lundbeck is a pharmaceutical company that develops products to treat people with psychiatric and neurological disorders.

H1B Sponsorship

Lundbeck has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)

Funding

Current Stage
Public Company
Total Funding
$566.37M
Key Investors
Michael J. Fox Foundation
2025-05-22Post Ipo Debt· $566.37M
2020-03-04Grant
1999-06-18IPO

Leadership Team

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Maria Alfaiate
Executive Vice President Commercialisation and Corporate Strategy
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Torben Frandsen
Vice President
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Company data provided by crunchbase