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Manager, Commercial Regulatory Affairs

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge
Start date
Feb 22, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country

Job Details

Title:

Manager, Commercial Regulatory Affairs

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Manager, Commercial Regulatory Affairs

Summary / purpose of the position

The Manager, Commercial Regulatory Affairs, is responsible for facilitating the promotional review committee (PRC) process of assigned products for Ipsen’s advertisements and promotional labeling materials. The individual will assure process compliance and efficiency of the ad/promo review cycle, including assessing that materials submitted for review are ready to progress, creating meeting agendas, managing meeting logistics and facilitating review meetings. This role is responsible for annotating materials during PRC review meetings, working with brand team member(s) to reconcile comments and progress materials through approval and release within established timelines. The individual will support Regulatory Reviewers in completing any post marketing submissions requirements. The individual will also support the processing of pre- and post-marketing submissions to the Office of Prescription Drug Promotion (OPDP). The PRC process utilizes significant cross-functional internal resources, and it is important that the PRCs are managed to function as teams that meet deadlines and adapt to the needs of the business while remaining compliant. To this end, the incumbent in this position will be responsible for 1) leading and managing all aspects of offline and live reviews interfacing with Brand Lead/Sponsor and Regulatory to assist with system execution of Regulatory submissions, 3) and providing training to PRC team members on processes and procedures. The expected outcome of this role is to increase compliance and efficiency related to the review and approval of promotional materials for Ipsen prescription drug products in the US.

Main responsibilities / job expectations

Responsibilities will include, but are not limited to, the following:

  • Material management for assigned products
    • Manage adherence to Standard Operating Procedure (SOP) guidance and timelines for submission of Materials into PRC review
  • Lead PRC meetings, along with the routing, approval and release of materials
    • Progress materials efficiently through the workflow in accordance with published timelines
    • Lead and facilitate efficient PRC related meetings and focus on key issues, with the goal of bringing the group to consensus; accurately capture discussion outcomes
    • Ensure all Reviewer comments on Materials are clarified, reconciled, and incorporated prior to final approval of materials
    • Collaborate with Regulatory Reviewers and Brand Lead/Sponsor to facilitate revisions to Materials upon updates to approved product labels
    • Manage expectations surrounding the expedited review process in accordance with the SOP.
    • Assist Brand Lead during PRC Escalation Meetings for assigned products with archiving outcomes in Veeva PromoMats
  • Manage review tool (Veeva PromoMats) and related functionalities
    • Monitor behaviors and practices to assure responsibilities defined in the PRC SOP are performed effectively by each role. Identify issues and communicate instances of noncompliance to Management
    • Ensure appropriate and efficient leverage of tool during PRC meetings
    • Participate in team meetings to discuss challenges and propose opportunities for process improvement
    • Trouble-shoot bottlenecks in workflow and incorporate process improvement feedback

Knowledge, abilities & experience

Education / Certifications:

  • BA/BS Degree preferred

Experience:

  • 5+ years professional experience working with promotional review committees Regulatory submission experience (Form FDA 2253 and Subpart E/H) strongly preferred

Languages:

  • Fluent English

Key Technical Competencies Required

  • Demonstrated expertise in Veeva PromoMats: Understand all steps in standard review workflows, corrective actions/troubleshooting, annotation functionality, agenda management, and report generation
  • Proficiency in Microsoft Office (Word, Power Point, Excel, Outlook) and Adobe Acrobat
  • Experienced with proofreading complex documents
  • Expert listening skills and ability to probe for undisclosed information
  • Excellent interpersonal skills; accurate and concise oral communications and writing ability
  • Must be able to foster a team environment, collaborate cross functionally and at varying levels of experience to establish high-performing PRC Teams
  • Basic knowledge of pharmaceutical promotional regulations and submission requirements
  • Exceptional attention to detail
  • Ability to lead and facilitate productive and efficient meetings
  • Ability to manage processes/workflows, implement process improvements, & solve problems
  • Ability to conduct process training to internal employees and vendors

The annual base salary range for this position is $91,500-134,200

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Company

Ipsen (Euronext: IPN; ADR: IPSEY) is a global, biopharmaceutical group focused on innovation and specialty care. The group develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen's North American operations and headquarters are located in Cambridge, Massachusetts, where our fully integrated biopharmaceutical team across External Innovation and Partnering, Research & Development (R&D), Manufacturing and Commercial collaborate. Cambridge is home to Ipsen's third global hub, in addition to R&D centers in Paris-Saclay in France and Oxford in the United Kingdom. With additional offices in Basking Ridge, N.J. and Mississauga, Ontario, Ipsen employs approximately 600 people in North America. For more information on Ipsen in North America, please visit www.ipsenus.com or www.ipsen.ca.

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Company info
Website
Phone
617-679-8500
Location
1 Main Street
Unit 700
Cambridge
MA
02142
United States

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