Senior Manager Sample Compliance and Fleet Management

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? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

Remote Opportunity - Open to candidates anywhere in the Greater United States

POSITION SUMMARY:

The Senior Manager, Sample Compliance and Fleet Management will have primary responsibility over all operational aspects of Sample Compliance and Fleet Management activities. This role will work cross-functionally to develop processes, manage system enhancements, create metrics and reporting, and implement training necessary to execute on all aspects of sample compliance and fleet management activities; including budget management, oversight and management of third-party vendors and ensuring initiatives are in-line with the Company's objectives and are executed in an efficient and compliant manner.

ESSENTIAL FUNCTIONS:

• Collaborate with multiple functional areas to manage the day-to-day operations for sample compliance and fleet management activities.
• Ensure compliance with company standard operating procedures (SOP's) and business processes relating to sample compliance and fleet management activities.

• Collaborates with third party vendors to ensure that samples have been accounted for, transferred, returned, and processed appropriately. Triage and escalate compliance concerns to Corporate Compliance and Legal to ensure adequate follow-up and solution.
• Prepare reports and perform root cause analysis, as required, and delivery of outputs to ensure efficiency and compliance requirements are met.
• Perform and implement Corrective Actions and Preventive Actions (CAPA) as corrections or improvements to organization's processes to eliminate non-conformities/adverse situations.
• Conduct investigations and follow up for HCP sample disbursement verifications with HCP office/accounts.
• Partners with Sample Operations to monitor, conduct follow up, and closure of transactional issues and appropriate documentation/tracking.
• Monitor and provide coaching to field sales representatives to comply with sample SOP's and PDMA guidelines.
• Chairs the sample compliance cross-functional team meetings.
• Lead the management of the annual storage inspection and inventory audit.
• Oversee quarterly sample inventory reconciliation and preparation of leadership summary
• Lead sample compliance meetings and manage vendor reporting to FDA sample loss/threshold requirements.
• Oversee the collection and FDA and state sample reporting.

• Monitor all facets of fleet Management, including inventory, safety, driver tax compliance, fuel, etc.
• Ensure outstanding, ongoing support is provided to drivers (from both internal and external resources) with any and all vehicle related issues.
• Initiate vehicle selections and negotiate fleet contract when necessary; decide on fleet options that meet Lundbeck's sustainability goal and safety requirements.
• Identify internal and external tasks/responsibilities and processes related to the fleet program, train internal employees against those processes.
• Provide recommendations on fleet program enhancements and policy changes/exceptions.
• Plan and prepare annual budget, expenditures and analyze all financial objectives, including monthly invoice reconciliation.
• Chair the Fleet Review Committee.
• Oversee the collision management process and establish risk management strategies.
• Monitor and identify drivers with significant violations and if necessary, report such drivers to Human Resources.
• Audit fleet inventory, research and provide solutions for insurance issues, fleet maintenance decisions, annual replacement activities.
• Maintain all fleet policies and advises field employees and executive team of changes. Provides compliance reporting to management.
• Coordinate on-boarding and off-boarding activities Plan and administer a preventative maintenance and vehicle replacement program for company owned vehicles.
• Receive and process vehicle accident and damage reports
• Other duties as assigned.

• Accredited Bachelor's degree
• 5+ years of work experience with a minimum of 3 years of commercial operations or compliance experience in the pharmaceutical, medical device, biotech or healthcare industry
• Solid verbal and written communication skills: Ability to interface with all levels of Lundbeck employees and external partners, vendors, customers, agencies and affiliates
• Strong analytical skills: Ability to read and analyze financial statements and related reports and make decisions based on that analysis.
• Demonstrated leadership ability: Must demonstrate qualities of action-oriented leadership, administrative ability, and public relations skills. Ability to plan, initiate, direct, and carry out short and long-term programs.
• Self-Motivated: Organized and possess ability to achieve assigned results with minimal direction. Ability to analyze data and develop insights to inform fleet management on compliance, improvement opportunities and performance management.

• 2+ Fleet Management experience
• 2+ years in sample compliance or compliance role in a regulated industry
• Demonstrated experience managing cross-functional teams and projects

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