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

SUMMARY:
The Manager, Commercial Operations Compliance will have primary responsibility over all operational aspects of Sample Compliance and the Credentialling and Jurisdiction program. This role will work cross-functionally to develop processes, manage system enhancements, create metrics and reporting, and implement training necessary to execute on all operational aspects of sample compliance and support the credentialling and jurisdiction program; including adherence to budget, oversight and management of third-party vendors and ensuring initiatives are aligned with the Company’s objectives and policies and are executed in an efficient and compliant manner. In addition, this role will support other commercial operations compliance initiatives, including Commercial Operations-led investigations and auditing of Speaker Program and Fleet programs and partnering with and escalating to Corporate Compliance as appropriate.

 

ESSENTIAL FUNCTIONS:

Close collaboration with the Associate Director, Commercial Operations and the Sample Management vendor to ensure the field remains compliant with all applicable standard operating procedures (SOPS), laws and regulations that govern sample programs. Collaborate 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. 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 company SOP’s and PDMA guidelines. Lead the management of the annual storage inspection and inventory audit. Oversee quarterly sample inventory reconciliation and preparation of leadership and compliance summaries. Lead sample compliance meetings and manage vendor reporting to FDA sample loss/threshold requirements. Oversee the collection and FDA and state sample reporting. Chair the sample compliance cross-functional team meetings. Work with internal stakeholders to update and distribute state price disclosure forms as needed. Oversight and management of the Credentialling and Jurisdiction program and selected vendor to ensure representatives meet the qualifications and comply with the regulations required to access healthcare facilities and address any issues and field questions as needed. Responsible for audits and investigations related to HCP sample signature verification, potential violations of Fleet and Speaker Program SOPs/guidelines d to monitor and address non-compliance. Escalate policy violations to Corporate Compliance when appropriate to determine if additional action is needed. Other duties as assigned.

 

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

Accredited bachelor’s degree. 5 years overall experience in the pharmaceutical, biotech, medical device or at an agency, vendor, consultant supporting one of these industries. 3+ years of sampling operations/sample compliance experience in the pharmaceutical industry or at an agency, vendor, consultant supporting the pharmaceutical industry. 1+ years of Veeva/salesforce.com (or similar systems) sample administration experience. A strong foundation for all aspects of program and process implementation and compliance –including business rules and requirements documentation, project management skills and budget adherence. Proficient in Excel and Microsoft Word. Proven ability to take initiative and manage multiple projects simultaneously. Strong verbal and written communication skills, with an ability to effectively communicate with both technical and non-technical subject matter experts.

 

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

3+ years’ experience with The Prescription Drug Marketing Act. 2+ years leading cross-functional teams. 2+ years managing/coordinating vendor activities. Experience with contracting processes.

 

TRAVEL:

Willingness/Ability to travel up to 20% 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: $125,000 - $140,000 and eligibility for a 10% bonus target based on company and individual performance. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site. Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote

 

Why Lundbeck

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

 

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.

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At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

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At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

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