An excellent opportunity has arisen for an experienced Regulatory Advertising and Promotional specialist to join an Oxford based Biopharma on an initial 12 month contract basis.
Within this role you will support the Regulatory Affairs Department and serve as an internal expert on European (EFPIA) and International (ex-US) regulations governing the promotion of prescription pharmaceutical products. One of the main responsibilities will be to support the implementation of Veeva Promomats across the EU/ROW region.
*Responsible for maintaining a process and collaborating on establishing standards to ensure that promotion for products in markets supported comply with company policies and SOPs, while maintaining consistency across markets in the core promotional efficacy claims and risk information.
*Support EU/ROW marketing and medical teams by participating in strategy discussions and extended team meetings (e.g. brand team, brand planning, etc.). Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics.
*Lead the promotional material review process and make decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of applicable EFPIA/International promotional regulations, corporate standards and policies and business objectives. Taking responsibility for the review and approval of International Promotional materials from a regulatory perspective.
*Support development of and adherence to company policies, processes and standards for promotional compliance and participate in the revision, update and approval of EU/ROW SOPs, policies and associated materials, including the development, integration and update of local processes and standards for promotional material review.
*Support to EU/RoW Medical Affairs activities by providing regulatory review of scientific publications and scientific oral and poster presentations as well as other medical programs and tactics.
*Assist in the compilation of EU/ROW stakeholder requirements to inform PromoMats configuration to ensure compliance in local markets. Assist in the identification of and develop solutions to obstacles to smooth and timely implementation escalating issues where required. Produce ad hoc reports and track milestones until project completion
*Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred
*Track record of increasingly responsible experience in the pharmaceutical industry, including direct experience in advertising and promotional material review. Experience of using Veeva PromoMats electronic approval system is desirable.
*At least two years' experience in the Advertising & Promotion field, including excellent working knowledge of IFPMA, EFPIA, and ABPI related advertising codes
*A qualification in or recent direct experience of project management is desirable.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to firstname.lastname@example.org