International Advertising and Promotion Lead (Hematology) - Global Regulatory Affairs
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International Advertising and Promotion Lead (Hematology) - Global Regulatory AffairsApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our International Advertising and Promotion Lead - Global Regulatory Affairs in our Zurich office.
As our Lead International Advertising and Promotion (A&P) you will serve as an internal expert on International, EFPIA regulations, guidance governing the promotion of prescription drug and biologic products and disease awareness activities.
You will provide 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.
Assist in the development, integration, and implementation of internal policies, work instructions, guidance and regional and LOC specific requirements, in collaboration with the A&P Group Lead.
You will be our process expert and will be the Lead for applicable A&P projects to ensure collaboration with key stakeholders and completion as planned.
Work collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial and Ethics & Compliance organizations and applies expertise to ensure that the development of promotional and disease state materials is accomplished through compliance with internal processes and standards.
Responsible for selected LOC’s in a designated region to support the strategy and integration and implementation of the Local review process variations, working instructions and assist in local complaint management in order to ensure consistency with the International processes.
Support the development, integration and implementation of directed and agreed future development and improvement of the global review process, standards
Key Accountabilities and Key skills required
- Evaluate 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 labelling. Provides consistent, well-supported, and clear guidance to key stakeholders.
- Serve as the chair of CMLR review meetings and assists Commercial with the planning and prioritization of proposed promotional and disease state materials.
- Provide expert guidance related to Regulatory strategy to commercial and key stakeholders during early development of projects to ensure promotional goals can be achieved (e.g., target product profile; clinical trial recruitment materials).
- Participate in CMLR meetings to resolve potential issues and participates in escalation meetings, as needed.
- Support metrics to measure and track effectiveness and efficiency of the CMLR review process; provides recommendations for process improvements to address issues, gains agreement of process improvements from key stakeholders, and helps implement agreed-upon process improvements.
- Understand broad concepts within regulatory affairs and potential implications across organization. Proactively identifies regulatory issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Lead internal A&P project workstreams (e.g., guidance documents) and active participant at team staff meetings
- Be the contact point and expert matter for the promotional review process and International review standards for selected LOC’s within the designated region
- Support 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.
- Address unmet LOC needs for selected LOC’s within the designated region through LOC discussions and the development of online collaboration tools.
- Be the 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 CMLR review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
Education, Competencies and Skills
- Bachelor’s Degree in a science-related field
- Ability to understand EFPIA and International (ex-US) regulations basics 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
- Demonstrated ability to clearly and concisely communicate.
- 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.
- Experience in International review and approval process of pharmaceutical/ biologics promotion
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 realise 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.
Discover more at takedajobs.com.
What Takeda Can Offer You
To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Contributory Pension Scheme, Private Health Cover and Life Assurance.
Empowering Our People to Shine
Learn more at takedajobs.com
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Job ID SR0042336