Review and Approval Operations Lead

ROLE SUMMARY

The U.S. Review and Approval Operations Lead is first and point of contact for market(s) on all relevant promotional operations related matters. This role actively supports promotional operations across assigned portfolio of U.S. focus brands. This role may be dedicated to RC Captain role as needed in support of focus brand, serving as leader and arbiter of a cross-functional group of colleagues (including Medical, Legal, and Regulatory reviewers) within the review and approval process while aiding the brand marketers through the process. Outside of daily RC support activities, this role monitors, consults and coaches RC stakeholders and shall be seen as experts in the Promotional Review and Approval process providing operations point of view, setting the bar for high-performing RC, driving operational effectiveness and identifying opportunities for continuous improvement. Manage measurement and oversight of RC effectiveness in partnership with other roles in the CMO to ensure Commercial and MLR Brand RC partnerships are clear, resulting in high-performing RC and high-levels of adoption of new Promotional Operation initiatives/capabilities and sustainability.

ROLE RESPONSIBILITIES

The U.S. Review and Approval Operations Lead will serve as a partner to Brand Marketing as the RC guide and subject matter expert while working closely with MLR in the ongoing review and approval of promotional materials and tactics for a given brand. The core responsibilities include: · Partnering with brand marketing for access and visibility into ongoing promotional programs · Working with Brand Managers and partnering agencies as the dedicated RC SME; serving to aid in the management and preparation of submissions for RC · Serve as the lead for RC meeting management, including agenda oversight and in-meeting orchestration/moderation · Leverage GCMA and any related platforms and tools to monitor the review and approval process; communicate outcomes. Shall identify and implement best practices across review/approval landscape and participate in projects to evolve process, systems and policy.

BASIC QUALIFICATIONS

• Bachelor's degree required ·
• 7 years of relevant experience with a minimum of 3 years' experience in pharma · Understand the fundamentals of the pharmaceutical industry, regulatory requirements, and risk management ·
• Proven ability to influence without authority, a wide range of senior stakeholders ·
• Demonstrated extensive experience of aligning senior stakeholders and facilitating conflict · Experience of working across cultures and multiple time zones ·
• Detail-oriented with strong organizational skills and a proven ability to prioritize and work independently to complete quality work on a timely basis ·
• Proven ability of strong networking and negotiation skills ·
• Demonstrated strategic thought leadership & ability to drive transformation ·
• Experience in project management and facilitating cross-functional initiatives via indirect ·leadership
• Strong analytical skills; ability to analyze information, draw insights and recommend improvements; ability to synthesize problems and develop solutions and strategies
• Team collaboration spirit, with strong ability to work as a single driver and contributor
• Strong written and oral communication skills with focus on issue understanding and resolution
• Proficient in common technical tools (e.g., Microsoft Office)
• Language skills: fluent in English

PREFERRED QUALIFICATIONS

• 7-10 years of pharmaceuticals experience in functions like marketing or operations, or comparable ·
• Strong understanding of U.S. promotional guidelines and compliance within the pharmaceutical industry ·
• Proven experience in working with or in the U.S. MLR process (or Medical, Legal, Regulatory Review) ·
• Proven track record of delivering business performance ·
• Drive for optimization/excellence and process improvement · Delivery of exceptional customer services and experiences ·
• Track-record for helping sustain strong cultures ·
• Strong ability to drive collaboration and foster highly productive cross-functional relationships ·
• Demonstrated agility and ability to drive program completion in expedited timelines ·
• Strong project management and prioritization skills with the ability to infl