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Clinical Data Manager II

Company: AbbVie
Location: Sunnyvale
Posted on: November 11, 2019

Job Description:

This staff is responsible for regulatory review and approval of commercial materials for respective products/indications. Contributes to strategic regulatory advice on advertising and promotion materials and activities for assigned products in accordance with business goals and objectives, FDA regulations/guidelines, PhRMA guidelines and company policy. Influences teams for assigned products and projects to implement compliant product labeling and communications. Facilitates the smooth operation of the company's Materials Approval and Review Committees (MARC) process for assigned indications. The MARC scope includes Promotional, Scientific and Corporate communications. All relevant products or candidates are in the hematology/oncology therapeutic space. Key Accountabilities/Core Job Responsibilities:

  • Serves as a reviewer for assigned indications on MARC teams, supporting the AD of RA. This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance.
  • Applies regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks.
  • Provide promotion integrity advice and guidance on the development of the draft labeling for assigned indications to ensure commercially viable US labeling upon which future promotion and advertising will be based.
  • Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
  • Understands global promotional strategies and provides solution to local US regulatory promotional issues.
  • Maintains awareness of competitive activities. Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of appropriate FDLI, DIA and other industry/FDA meetings.
  • Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures within the scope of the Regulatory Affairs Advertising, Promotion.
  • Candidate to assist with additional regulatory projects as needed.
    • Must perform independently with strong problem solving, negotiation and decision making skills by balancing autonomy and teamwork.
    • Must possess strong interpersonal, collaboration and communication skills. Has the ability and interest to be both a team leader and a team player.
    • Excellent verbal and written communication skills. Ability to represent regulatory in cross-functional teams. Strong interpersonal skills and ability to work in a small/medium size company setting.
    • Excellent knowledge and understanding of US regulations for drug promotion/advertising and US labeling, prior experience in oncology or hematology drugs strongly preferred.
    • Experience in the regulatory review of professional and consumer Rx drug advertising and promotion.
    • Experience in leading activities for pre-clearance and 2253, "time of first use" submissions.
    • Experience with regulatory activities involved with a product launch.
    • Strong understanding of business goals of the involved business franchise, marketing concepts and tools.
    • Strong project management skills with the ability to collaborate and manage with all stakeholders to adhere to timelines and deadlines. Work independently on assigned projects within timelines. Great attention to detail and ability to interpret clinical and scientific data. Education Requirements:
      • Advanced degree required, advance allied health degree such as MS of nursing, PharmD, MD, NP, PhD. Prior experience in clinical development or medical affairs very beneficial.
      • Minimum of 3-5+ years of relevant Regulatory Affairs, Advertising and Promotional Materials experience in the pharmaceutical/biotechnology industry, ideally prior experience with Orphan Drugs and Subpart H approval.

Keywords: AbbVie, Sunnyvale , Clinical Data Manager II, Executive , Sunnyvale, California

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