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US Compliance Manager

Company: Ascendis Pharma
Location: Princeton
Posted on: January 16, 2022

Job Description:

Ascendis Pharma - a visionary and ambitious company - offers you the opportunity to become a major participant on our journey towards becoming a leading rare disease company.

To support our rapid growth, we are looking for an experienced and ambitious colleague to join the Compliance Team.

In this position, you will support internal Compliance and manage, support and train the organization in the development of compliant material and support legal issues relating to promotion, advertising and communications of materials related to biopharmaceutical products, such as sales material, ad board material, social media communications, corporate communications, medical communications, and other activities.

You will regularly interact with the Marketing and Sales organization, US Communications, Investor Relation and other departments that communicate externally and need legal promotional advice. You will support the organization in establishing solid processes to support the development of compliant materials in a rapidly changing environment in a new organization.

You will become part of the Ascendis Pharma Compliance Team with 3 colleagues in the US and will report directly to the VP, Head of Compliance, located in the Copenhagen headquarters. You will be based in our office in Princeton, but you will also work with our teams in our Palo Alto Office as well as in Copenhagen.

Key Responsibilities

  • Provide legal advice on relevant laws, regulations, and rules regarding promotional, advertising and communications in relation to commercialization of biopharmaceutical products, marketed and investigational, including but not limited to the Food, Drug and Cosmetic Act, and implementing regulations promulgated by the FDA pertaining to drug labeling and the advertising and promotion of pharmaceutical products.
  • Review and advise with respect to both pre-promotional and promotional materials, programs, activities, and disease awareness for compliance with applicable federal and state requirements on promotional advertising.
  • Continuous training of the organization in relevant laws and regulations in relation to promotion, advertising and communications.
  • Support concept reviews and support the organization in the development of processes for development and quality checking of materials.
  • Be part of the Promotional Review Committee (PRC) along with Regulatory Affairs, Medical Affairs, and ad hoc reviewers, to support the review and approve advertising and promotional materials in accordance with applicable SOPs, laws and regulations.
  • Be part of the Medical Review Committee (MRC) to support the review all medical activity concepts and medical communication materials in accordance with applicable SOPs, laws and regulations.
  • Provide counseling with respect to corporate communications, both externally and internally (e.g., press releases, bulletins, newsletters, social media posts, and other digital communications).

    Requirements
    • BA or BS from a recognized college or university. Life Science major is a plus.
    • JD degree from an accredited law school and admitted to practice law in at least one state.
    • 3+ years of experience as a legal professional with relevant experience dealing with advertising, promotion, and commercialization of products at a pharmaceutical company or law firm.
    • Thrive on building relationships as well as providing support and training.
    • Excellent verbal and written communication skills.
    • Ability to actively participate in committee meetings and productively add value to group dynamics and group discussions and propose pragmatic solutions or alternatives in real time.
    • Ability to influence and counsel other business partners.
    • Ability to recognize risks and the ability to think of workable strategies to mitigate such risks.
    • Must possess the ability to calibrate responses to risk.
    • Strong negotiations skills.
    • Strong strategic thinking skills and ability to translate strategy into an effective action plan.
    • Must be a team player who is collaborative and resourceful.
    • Want to work in-office and build up the organization and cooperation with colleagues.

      Benefits
      • Medical insurance
      • Vision insurance
      • Dental insurance
      • 401(k)
      • Paid maternity leave
      • Paid paternity leave
      • Commuter benefits
      • Disability insurance

Keywords: Ascendis Pharma, Trenton , US Compliance Manager, Executive , Princeton, New Jersey

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