Manager, Promotional Regulatory Review
ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people--a fact that's reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated. ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond. The regulatory landscape is constantly evolving, and that healthcare companies are expected to adhere to complex legal, regulatory and industry standards. Traditional approaches to fostering compliance can be resource-intensive, ineffective and a barrier to progress. More specifically, pharmaceutical and device companies are under pressure to develop and deliver personalized content to healthcare professionals through a variety of channels in a timely, innovative, and compliant manner. With increased Digital acceleration, companies are ramping up their content supply chain programs and investing into modular content, all of which requires innovative approaches to medical, legal, and regulatory approval processes at massive scale. ZS is uniquely positioned to integrate deep expertise in strategy, analytics, technology, and regulatory risk management to empower clients to reimagine operations that support innovative and compliant promotional and medical communications. In this role, you will:
Deliver and build on our existing offerings to meet unique client needs in the areas of promotional regulatory review for promotional and medical communications Work with client teams to ensure they can perform promotional regulatory reviews in a complete and timely manner to support innovation Understand government promotional regulatory requirements and guidance to support implementation of strategies and solutions that align to government standards and internal policies/procedures Proactively identify process and system improvements to support an effective promotional regulatory review process Lead and manage client projects and ZS teams to re-engineer and innovate medical, legal, and regulatory (MLR) processes using data, analytics, and technology, to significantly improve content approval productivity Partner closely with the Medical, Regulatory Affairs, Marketing, and Training groups to assess and determine the resource needs for review Help clients capitalize on digital asset management (DAM) systemsto enable effective and timely promotional regulatory reviews Develop a team that can specialize in delivering MLR transformation and re-engineering processes Establish and maintain positive relationships with client stakeholders and team members Partner with ZS practices to develop thought leadership and offerings that blend the best of our thinking on commercial/medical issues with a deep understanding of compliance requirements so that compliance is seen as a positive enabler of commercial/medical innovation Partner with client teams to identify project and transformation opportunities where bringing an integrated perspective on compliance will create a meaningful impact Leverage personal network and collaborate with client teams to drive discussions with Regulatory Affairs, Medical Affairs, Legal, Compliance, and Business leads at clients to understand and ultimately shape their agenda What You'll bring:
Education:
Bachelor's degree in Business Administration, Legal Studies, or related field Preferred:
advanced degree or comprehensive training/certification relevant to possessing deep domain knowledge in promotional regulatory affairs and/or healthcare compliance Required Skills:
Minimum of 10 years of combined pharmaceutical, legal, regulatory affairs, and Compliance experience - - ideally with direct experience in both govt. and industry Prior management consulting experience Prior expertise working with Brand Marketing and Digital Teams on promotional material clearance processes Prior leadership experience, with a history of successfully building new teams Demonstrated ability to quickly assimilate new knowledge Executive-level presence and communication Demonstrated ability to deliver compelling conference presentations and white-papers A willingness to travel to meet client needs Demonstrated ability to develop, maintain and grow relationships Demonstrated success with oral and written communications/presentation, results orientation, facilitation, and teamwork skills ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable. Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. We are an Equal Opportunity Employer. NO AGENCY CALLS, PLEASE.
Salary Range:
$150K -- $200K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
Deliver and build on our existing offerings to meet unique client needs in the areas of promotional regulatory review for promotional and medical communications Work with client teams to ensure they can perform promotional regulatory reviews in a complete and timely manner to support innovation Understand government promotional regulatory requirements and guidance to support implementation of strategies and solutions that align to government standards and internal policies/procedures Proactively identify process and system improvements to support an effective promotional regulatory review process Lead and manage client projects and ZS teams to re-engineer and innovate medical, legal, and regulatory (MLR) processes using data, analytics, and technology, to significantly improve content approval productivity Partner closely with the Medical, Regulatory Affairs, Marketing, and Training groups to assess and determine the resource needs for review Help clients capitalize on digital asset management (DAM) systemsto enable effective and timely promotional regulatory reviews Develop a team that can specialize in delivering MLR transformation and re-engineering processes Establish and maintain positive relationships with client stakeholders and team members Partner with ZS practices to develop thought leadership and offerings that blend the best of our thinking on commercial/medical issues with a deep understanding of compliance requirements so that compliance is seen as a positive enabler of commercial/medical innovation Partner with client teams to identify project and transformation opportunities where bringing an integrated perspective on compliance will create a meaningful impact Leverage personal network and collaborate with client teams to drive discussions with Regulatory Affairs, Medical Affairs, Legal, Compliance, and Business leads at clients to understand and ultimately shape their agenda What You'll bring:
Education:
Bachelor's degree in Business Administration, Legal Studies, or related field Preferred:
advanced degree or comprehensive training/certification relevant to possessing deep domain knowledge in promotional regulatory affairs and/or healthcare compliance Required Skills:
Minimum of 10 years of combined pharmaceutical, legal, regulatory affairs, and Compliance experience - - ideally with direct experience in both govt. and industry Prior management consulting experience Prior expertise working with Brand Marketing and Digital Teams on promotional material clearance processes Prior leadership experience, with a history of successfully building new teams Demonstrated ability to quickly assimilate new knowledge Executive-level presence and communication Demonstrated ability to deliver compelling conference presentations and white-papers A willingness to travel to meet client needs Demonstrated ability to develop, maintain and grow relationships Demonstrated success with oral and written communications/presentation, results orientation, facilitation, and teamwork skills ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable. Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. We are an Equal Opportunity Employer. NO AGENCY CALLS, PLEASE.
Salary Range:
$150K -- $200K
Minimum Qualification
Legal & RegulatoryEstimated Salary: $20 to $28 per hour based on qualifications.
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