HCP Signatory Lead EUR/INT (Remote)

Jazz Pharmaceuticals · 22 days ago
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The Director HCP Signatory Lead EUR/INT is a member of the Medical and Promotional Regulatory Affairs group within the Global Medical Affairs Department, leading the EUR/INT HCP signatory team. This role is a member of the Global Medical and Promotional Regulatory Affairs leadership team.Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.This role is responsible for driving medical excellence through focus on medical quality and standards and guiding global functions including marketing and medical to undertake internal and external activities in a compliant and ethical manner. This individual leads the nominated signatory team and provides training and education to colleagues globally in the code of practice. This individual advises, reviews, and approves materials and events produced by the global functions and serves as an internal expert on European (EFPIA) and International (ex-US) regulations governing the promotion of prescription pharmaceutical products. The role provides strategic input for EUR/INT promotional/medical materials and activities. This role works collaboratively with the EUR/INT Medical, Legal, Compliance and Commercial organisations and apply expertise and organisational influence to ensure development of programs and tactics that are compliant with regulations, relevant codes of conduct and company policies, while supporting achievement of business objectives. This position must be capable of representing the medical perspective and applying expertise and organizational influence with cross functional teams and company leadership.Essential Functions:Lead the EUR/INT medical review process and represent the medical view to escalation committees.Lead, manage and develop other reviewers/signatories within the teamReview and approve for distribution promotional and non-promotional materials, activities, concepts and draft materials to satisfy the letter and spirit of applicable ABPI/EFPIA/International codes of practice promotional regulations, corporate standards and policies.Act, when required, as a final signatory for items and activities that do not undergo local affiliate approval.Advise global brand teams and global medical affairs teams on development activities including brand strategy, target product profiles, target product claims and target product label while striving to optimise innovationSupport EUR/INT commercial activities by providing review of market research and market access programs and tactics.Support EUR/INT marketing and medical teams by participating in strategy discussions and extended team meetings (e.g. brand team, brand planning, global regulatory team etc.). Provide medical strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics.Support the affiliate company Medical colleagues in their review and approval by sharing interpretations of codes and policies and medical standards.Provide medical guidance to Global Medical Affairs and Jazz corporate projects as needed.Support the training of stakeholders on the Jazz review and approval process and Code requirements in the EUR/INT region.Support development of and adherence to company policies, processes and standards for promotional compliance and participate in the revision, update and approval of EUR/INT SOPs, policies, and associated materials.Maintain a deep and current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to advertising and promotion.Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or process changes as needed.Work collaborativley to find solutions to medical material review challenges and implement process enhancements as needed.Indentify and implement innovation, seek out business opportunities and new ways of workingRequired Knowledge, Skills and Abilities:Direct experience in promotional and non-promotional material review, with at least 2 years’ experience acting as a final medical signatoryDemonstrated ability to lead and manage a team independentlyHas a deep knowledge of regulatory requirements and applicable external codes (including IFPMA, EFPIA and ABPI)Successfully completed ABPI training / certification and achieved Final Medical Signatory StatusAbility to represent a medical perspective and applying expertise and organizational influence with cross functional teams and company leadershipStrong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire company.Ability to discuss ethical and medical issues with credibility and authority.Outstanding verbal and written communication skills.Required/Preferred Education and Licenses:Required: eligibility to act as a final medical signatory as per ABPI, including being a GPhC registered Pharmacist, or a registered medical doctor (should be capable of being registered in the UK) with experience working as a final signatoryExperience in the pharmaceutical industry including Medical Affairs or/and Compliance.Jazz Pharmaceuticals is an Equal Opportunity Employer.
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