Director, Global Regulatory Affairs, Advertising & Promotion - Oncology - Remote

Company: Takeda Pharmaceuticals
Location: Lansing
Posted on: September 23, 2022

Job Description:

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Advertising & Promotion - Oncology - Global Regulatory Affairs in our Cambridge, MA office or role can be performed remotely (virtually). This will be an Individual Contributor position.Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Director, Advertising & Promotion working on the Global Regulatory Affairs team, you will be empowered to lead the review, submission and execution of advertising and promotional items across 2 or more therapeutic areas and a typical day will include: OBJECTIVES As an Individual Contributor, you will:

• Lead Regulatory Affairs initiatives to ensure all promotional items are prepared and executed in accordance with applicable regulations and guidelines and company policy.
• Lead, manage or negotiate any major issues with FDAs Office of Prescription Drug Promotion (OPDP) as required.
• Mentor and develop skills of staff.ACCOUNTABILITIES
  • Oversees regulatory guidance provided by team to ensure compliance with promotional regulations.
  • Responsible for Global Processes and applications of codes and regulations for Global review of products.
  • Oversight/Accountable for all submissions within group. Approve enforcement responses.
  • Manages personnel within group to ensure coverage for brand and therapeutic area responsibilities.
  • Understand and interpret complex scientific issues as it relates to regulatory requirements and promotional strategy. Able to mentor and develop skills of staff.
  • Understands broad concepts within regulatory affairs and implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
  • Develops strategy for efficient and appropriate OPDP review and play a key role in life cycle management strategy such that scientific, regulatory and commercial plans are aligned for all areas of responsibility.
  • Identifies trends in Agency enforcement, policies and procedures; incorporates into regulatory decisions and strategy; responsible for establishing and maintaining a process for sharing enforcement trends etc, with appropriate TPUSA employees.
  • Reviews competitive materials and interacts with FDA to urge enforcement activity as necessary.
  • Develop department area by ensuring structure; organization and functional processes are aligned by ensuring compliance and defining SOPs and training of core team and business partners. Responsible for development and training of global review processes.
  • Works closely with Medical, Legal, OEC, Marketing, Marketing Operations, Sales, and Sales Training departments as well as external advertising agencies and consultants in the successful development of promotional and applicable training materials. Works to align promotional goals with the goals of the cross-functional MRL team.
  • Support development and maintenance of product labeling with Regulatory Affairs Labeling and Strategy groups. Support regulatory direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, SNDAs, etc)
  • Lead for Promotion and Advertising Regulatory Review for licensing opportunities
  • Other duties as assigned or neededEDUCATION, EXPERIENCE AND SKILLS
    • BS/BSc is required. Advanced scientific related degree: PhD or PharmD is preferred.
    • 10 years pharmaceutical or related industry; inclusive of > 8 years Regulatory, Medical Affairs or related experience.
    • Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement letters. Promotion and Advertising experience in multiple therapeutic areas
    • Prior people management required; multiple personnel for > 5 years preferred
    • Generally strong in working well within Regulatory, cross-functionally and communicating /negotiating with senior leadership.
    • Must be strong in strategic and problem solving skills over all with an ability to identify the critical issues of problems or opportunities using appropriate information and judge risk based on FDA trends; determines the causes and possible solutions to the problem.
    • Must be strong leader that creates vision for the group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Must have demonstrated outstanding judgment.
    • Ability to express ones self clearly and concisely; documents issues and/or concerns concisely and comprehensively; adjusts language and/or terminology appropriate to the audience; ability to communicate effectively with business partners and company management to enhance efficient, timely and balanced decision making. Must be especially strong in negotiation skills and integrity. Works well with others, especially on a cross-functional team. Demonstrated ability to effectively manage and bring together working teams together for common objectives. Presentation at industry meetings is desirable.
    • Ability to capture knowledge and share within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use
    • Ability to assist in the development of an operating budget to monitor and control expenditures.
    • Understands the phases, processes and techniques used within a clinical development environment, can contribute to clinical study design discussions as needed.
    • Understand FDA regulations relative to advertising and promotion, for health professional and consumer audiences. Experience in managing multiple filings e.g. Launch Advisory Materials or responses to enforcement or proactive complaints to OPDP about competitors.
    • Understands the pharmaceutical industry and has experience in evaluating promotion and advertising materials in multiple therapeutic areas.
    • Understands medical/therapeutic impact of products; understanding of potential product applications, and competitive products.
    • Understands Takedas operating structure and methods including a thorough knowledge of the foreign-owned parent company.
    • Maintains a current knowledge of applicable government regulations, particularly those related to advertising and promotion. Has a thorough knowledge of historical enforcement actions and is readily able to use this in negotiation.LOCATION:
      • Job Location: Role Remotely (Virtual)TRAVEL REQUIREMENTS
        • Up to 30%
        • Ability to drive or fly to various meetings/ client sites limited overnight. Some international travel may be required.WHAT TAKEDA CAN OFFER YOU:
          • 401(k) with company match and Annual Retirement Contribution Plan
          • Tuition reimbursement
          • Company match of charitable contributions
          • Health & Wellness programs including onsite flu shots and health screenings
          • Generous time off for vacation and the option to purchase additional vacation days
          • Community Outreach ProgramsEmpowering Our People to Shine Learn more at takedajobs.com#LI-VMEEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote

Keywords: Takeda Pharmaceuticals, Lansing , Director, Global Regulatory Affairs, Advertising & Promotion - Oncology - Remote, Executive , Lansing, Michigan