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If you believe you have been contacted by an unauthorized person, please contact your local law enforcement agency immediately.
Lead International Advertising & Promotion - Global Regulatory Affairs
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Lead - International Advertising and Promotion - Global Regulatory Affairs in our Zurich office.
Here, you will be a vital contributor to our inspiring, bold mission.
- The Lead International Advertising and Promotion (A&P) serves as an internal expert on International guidance, including IFPMA and EFPIA codes, governing the promotion of prescription drug and biologic products and disease awareness activities.
- Capable of providing regulatory strategic oversight for at least one (1) complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional and non-promotional materials generated for assigned products and/or compounds.
- Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance organizations to ensure that the development of promotional and disease state materials is accomplished in compliance with internal processes and standards.
- Assists in the development, integration, and implementation of global, regional and LOC specific requirements, internal procedures and work instructions.
- Serves as the process expert and is the lead for applicable A&P projects to ensure collaboration with key stakeholders.
- Responsible for selected LOC’s in a designated region to support the strategy and implementation of the local review process variations and assist in local complaint management in order to ensure consistency with the International processes.
- Evaluates materials to ensure compliance with International regulations, guidance, corporate standards and policies and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims that are consistent with product labeling. Provides consistent, well-supported, and clear guidance to key stakeholders.
- Serves as the chair of the Promotional Review Team meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- Provides expert guidance related to Regulatory strategy to commerical and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials).
- Supports metrics to measure and track effectiveness and efficiency of the Promotional Review process; provides recommendations for process improvements, gains agreement of process improvements from key stakeholders, and helps to implement agreed-upon process improvements.
- Understands broad concepts within regulatory affairs and potential implications across organization.Proactively identifies regulatory issues.Offers creative solutions and strategies, including risk mitigation strategies.
- Leads or supports internal A&P project workstreams (e.g., guidance documents) and actively participates at team staff meetings.
- Being the contact point and expert for the promotional review process and International review standards for selected LOC’s within the designated region.
- Supports the development, integration and update of the LOC processes and standards for promotional & non-promotional review and ensure full training implementation for selected LOC’s within the designated region.
- Addresses unmet LOC needs for selected LOC’s within the designated region through LOC discussions and the development of online collaboration tools.
- Being key contact person for selected LOC’s within the designated region for complaints regarding promotional or disease awareness materials/activities in the designated region to drive centralisation and global coordination and identify potential competitor trends or risks that require further legal action.
- Collaborates with the US Promotional Review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s Degree in a science-related field.
- Ability to understand IFPMA/EFPIA and International (ex-US) regulations on advertising and promotion for prescription products.
- Ability to understand the basics in pharmaceutical promotion development and review Process.
- Strong interpersonal skills with ability to demonstrate strategic and analytic thinking.
- Effective written and verbal communication skills in order to manage, motivate and drive decisions within teams.
- Proven skills in negotiation, influencing without authority and working diplomatically through conflict.
- Ability to work independently, take initiative and complete tasks to deadlines.
- Previous experience in advertising and promotion; experience in managing regulatory filing(s) or competitor complaints or medical communication/information.
- Minimum of 3 year experience in International review and approval process of pharmaceutical/biologics promotion
- International travel may be required
- Ability to attend offsite meetings that may involve overnight stay
WHAT TAKEDA CAN OFFER YOU
At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine
Discover more at takedajobs.com