Senior Manager, Regulatory Advertising and Promotional Review
Imbrium is a clinical-stage biopharmaceutical company dedicated to advancing medical science through the development of important new pharmacologic and biologic therapeutics. We are pursuing oncology chemotherapeutics, treatments for disorders of the central nervous system, and non-opioid approaches to the management of pain. As an operating subsidiary of Purdue Pharma L.P., Imbrium strives to develop and bring to market new medicines that serve the unmet needs of patients, physicians and health systems worldwide. We have built a robust and diversified pipeline of investigational drug candidates, and we actively collaborate with industry and academic partners to identify and advance future impactful medicines.
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to our Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!
This role is on the US Regulatory Labeling, Advertising and Communication team, and will provide strategic support to the review of Advertising and Promotion materials in order to meet US Commercial objectives while ensuring the necessary level of regulatory compliance including meeting Office of Prescription Drug Promotion (OPDP) directives. The materials can include advertising or promotional materials, slide presentations for corporate communications, training materials for salesforce, press releases and other outward facing materials. Responsible for evaluating all advertising/promotional regulatory issues; developing and reviewing regulatory strategies for promotion of marketed and pipeline products; and serves as the lead Regulatory Affairs representative on the MRL committee.
- Review promotional materials and ensure that they are (i) accurate, truthful and not misleading, (ii) presented in a fair and balanced manner, (iii) consistent with applicable product labeling, (iv) well-substantiated by current and scientifically valid evidence, (v) adherent to applicable advertising and promotion standards, and (vi) comply with all internal and external policies and procedures.
- Act as primary OPDP agency Liaison; Maintain and foster relationships with agency contacts in OPDP on an expert peer to peer basis.
- Perform Regulatory review of internal and external business communications as requested.
- Enhance collaboration across a matrixed organization while developing and maintaining constructive relationships.
- Provide support for potential new product launches, including promotional review of launch materials, implementation of OPDP advisory comment submissions, and interactions with the Agency.
- Monitor and share information on regulatory developments in Advertising and promotion.
- Effectively communicate regulatory issues and concerns to senior governance groups including Marketing, Legal and Medical, as necessary.
- Provide guidance for team on overall benefit/risk assessments of promotional activities and strategies.
- Assist with the development of policy and internal guidance on Advertising and promotion activities.
- Ensure business compliance and implementation of and adherence to Regulatory standards.
Additional Knowledge, Skills, and Abilities
- Work independently and recognize when issues need to be elevated to Management.
- Demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Strong negotiation and communication skills.
Education and Experience Requirements
- BS or equivalent is required. Science degree/advanced degree is preferred.
- Five + years prior experience as a regulatory reviewer of US Advertising & Promotion.
- Eight + years of overall pharmaceutical experience, ideally including exposure to general Regulatory Strategy and Product lifecycle management
- Experience interacting with FDA including OPDP.
- Demonstrated experience of effective delivery in complex matrix environment.
Supervisory Responsibilities (if Applicable)
Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: firstname.lastname@example.org.
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