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Director, US Regulatory Advertising and Promotion

Employer
Ipsen Biopharmaceuticals, Inc.
Location
Cambridge
Start date
Jun 12, 2024

View more

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

Job Details

Title:

Director, US Regulatory Advertising and Promotion

Company:

Ipsen Biopharmaceuticals Inc.

Job Description:

Director, US Regulatory Advertising and Promotion

Summary / purpose of the position

The Director, Commercial Regulatory Affairs will report to the Sr. Director and have accountability for review and approval of promotional and medical communications of assigned brand(s). The Director is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. The incumbent’s responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively. Medical communications will be reviewed and approved at MRC in a similar process to PRC. This position requires frequent interaction and strong collaboration with Commercial Marketing, Medical Affairs, PRC/MRC Coordinators, Legal Affairs, Regulatory Affairs Strategy, Labeling Operations and Business Ethics for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements, PhRMA DTC Guidelines and Ipsen policies.

Main responsibilities / job expectations

Responsibilities

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

  • Serve as the internal subject matter expert on FDA Advertising & Promotion issues for assigned product(s) providing regulatory advice and offering solutions to reconcile regulatory comments on draft promotional materials to maintain compliance with FDA regulations
  • Provide regulatory training as needed on FDA requirements, PhRMA DTC Guidelines and Company policy and leadership on assigned Promotional Review Committee(s) (PRC) with respect to best practices in compliance with company policies and guidelines for PRC processes. Demonstrate leadership as the regulatory reviewer on copy approval teams such that recommendations are recognized as well-reasoned, valid and appropriate
  • Develop SOPs and work instructions to facilitate stream-lined workflows and encourage proficient practice of process policy
  • Liaise with OPDP/FDA as needed for assigned product(s) serving as our company's single point of contact with FDA on matters related to advertising and promotional materials. Manage interactions with OPDP/APLB, including response to regulatory inquiries, preparation of complete, accurate, high-quality submissions for advisory comments, and as needed discussion with OPDP/APLB staff
  • Foster a business partnership environment grounded in trust and transparency between Regulatory and PRC partner functions in the review and approval of Ipsen product communications
  • Collaborate with partner functions to share commercial regulatory guidance on US Commercial Teams’ strategic imperatives

Lead PRC teams in management of tasks that help support compliant execution of Marketing tactics and programs: implementing revised product labels in promotional materials, establishing life-cycle of content, appropriate balance and risk information and requisite training materials for reps.

  • May manage junior staff

Knowledge, abilities & experience

Education / Certifications:

  • Minimum BS in scientific discipline

Experience:

  • Minimum of 8 years experience in the pharmaceutical industry and a minimum of 6 years in regulatory affairs
  • Experience in Rare Diseases, Neuroscience and/or Oncology a plus
  • Expert knowledge of advertising promotion regulations and FDA Guidance documents issued with some technical experience in aspects of drug development and labeling
  • Solid experience with promotional and medical review supporting product communications and working with FDA (OPDP, APLB) on advertising and promotion matters
  • Oversee OPDP submissions and author all submissions for assigned products

Languages:

  • English. French is a plus

Key Technical Competencies Required

  • Ability to understand and interpret clinical trial data. Expert understanding of FDA promotional regulations, product and therapeutic knowledge as well as evidentiary standards required to support product claims
  • Excellent oral and written communication and negotiation skills with strong attention to detail. Seasoned ability to spot issues and convey unique product facts, offering ideas and options as guidance to mitigate risks. Ability to articulate the impact to Ipsen associated with insufficient mitigation of risks.
  • Ability to influence and interact effectively across relevant functions within Ipsen and with regulators.
  • Demonstrate understanding of commercial objectives of the company and how outcomes can be delivered while meeting FDA compliance standards
  • Be an innovator of new ideas and best practices
  • Must anticipate and solve problems
  • Recognized as a leader, team player, and possess a cross-functional collaborative skill set
  • Ability to manage multiple activities or projects

The annual base salary range for this position is $177,000-$259,600.

This job is eligible to participate in our short-term incentives program as well as our long-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
US

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