Hiring Now!
Associate Director, Promotional Review and Operations - Remote Opportunity
Hiring Now!, Deerfield, Illinois, United States, 60063
Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!
SUMMARY:
This role is responsible for leading the approval process for all Lundbeck U.S. promotional materials through the required Medical, Regulatory, and Legal review. Will oversee and manage the associated systems that regulate and ensure compliance for advertising and promotion as well as overseeing materials inventory management. This position will lead individual team members as well as work cross-functionally to create processes, manage system enhancements, develop metrics and reporting, and implement training necessary to execute on all aspects of speaker program management. This position will ensure all promotional materials are reviewed and approved in a timley manner in accordance with all internal processes and procedures. These include, leading cross functional team meetings with various levels of management; lead for managing promotional items through label updates; ensuring materials are routed for review and are approved prior to first use; developing new processes and procedures; facilitating PARC/STRC Steering Committee meetings; and owning onboarding efforts as it pertains to PARC/STRC and Veeva.
ESSENTIAL FUNCTIONS:Leads cross-coordination and prioritization efforts for all PARC/STRC jobs within the USEnsures regulatory compliance of promotional materials while effectively managing business riskEnsures all logistical and operational support teams and priorities are aligned across all areas of the business as it relates to commercial execution of promotional materials and messagingMonitors regulatory promotional environment by reviewing regulatory promotional guidelines and untitled warning letters to companies published by regulatory agencies.Manages activities related to promotion and advertising including maintenance and preparation for electronic submission of promotional materials to regulatory agencies.Leads the effort, with brand team members and agencies, to develop review timelines and ensures materials are submitted following submission guidelines; proactively identifying discrepancies and resolving submission errors prior to routing promotional materials for review and approval.Coordinates with internal and external partners to manage the overall workflow, process and documentation through the internal review system in accordance with promotional review and approval (PARC), and sales training review and approval (STRC).Provides recommendations on phase IV clinical trial design with regard to marketing promotion possibilities of potential data/claims.Establishes and manages operational KPIs and develops associated PARC/STRC scorecards/reporting. Leads reporting and analytics regarding the review process, prioritization, label changes, launch initiatives, etc.Supports planning and preparation for monthly/Quarterly PARC Steering Committee meetings.Leads the team's training and onboarding as it relates to PARC/STRC and VeevaResponsible for oversight of the typesetting, printing, approval, and implementation of all promotional labelingLeads cross functional review team meetings with various levels of management, facilitates conversations which lead to resolution, proactively identifies gaps and potential issues, takes formal meetings notes, ensures proper documentation, and clearly identifies next steps for all reviews.Manages and coordinates material as it relates to a label change or product launch.Oversees all internal and external training on the process for promotional review and approval (PARC), and sales training review and approval (STRC).Oversees and provides direction on the inventory management of all promotional materials to ensure materials are warehoused, maintained, tracked and delivered within budget and are monitored for compliance.In conjunction with other Business Effectiveness stakeholders, develops long-term roadmap for the continued evolution of our CRM platform.Continuously looks for process improvements on current and future processes to allow for growth and continued efficiency.
REQUIRED EDUCATION, EXPERIENCE, and SKILLS:Accredited Bachelor's degree8+ years of direct experience in managing day-to-day responsibly of PRC/MRL processes in the pharmaceutical industryProficiency in Veeva PromoMatsExcellent organization and customer support skillsStrong verbal and written communication skills with ability to interface with all levels of Lundbeck employees, project teams, external partners, vendors, customers, agencies and affiliates.High level of attention to detailAbility to influence others to accept practices and approaches.Conflict resolution and negotiating skillsAbility to manage large projects and processes with limited oversight from managerCoaching, reviewing and delegating work individualsHighly proficient in managing multiple projects with varying degrees of complexity to timelinesWorking knowledge of FDA guidelines and laws which govern advertising and promotion in the pharmaceutical industry
PREFERRED EDUCATION, EXPERIENCE, and SKILLS:Veeva PromoMats Admin experience strongly preferredPharmaceutical marketing or sales experience preferredCross functional project management experience specifically related to promotional materials in a regulated industryExperience working within a commercial organizationExperience typesetting and implementing labeling into promotional materialsAt least 3 years of people management experience (contractor or FTE)
TRAVEL:Willingness/Ability to travel up to 10% domestically. If based remotely, additional travel will be required to Deerfield, IL. International travel may be required.
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $170,000 - $200,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site . Applications accepted on an ongoing basis.
#LI-Remote #LI-CP1
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site .
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site .
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify .
About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.
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SUMMARY:
This role is responsible for leading the approval process for all Lundbeck U.S. promotional materials through the required Medical, Regulatory, and Legal review. Will oversee and manage the associated systems that regulate and ensure compliance for advertising and promotion as well as overseeing materials inventory management. This position will lead individual team members as well as work cross-functionally to create processes, manage system enhancements, develop metrics and reporting, and implement training necessary to execute on all aspects of speaker program management. This position will ensure all promotional materials are reviewed and approved in a timley manner in accordance with all internal processes and procedures. These include, leading cross functional team meetings with various levels of management; lead for managing promotional items through label updates; ensuring materials are routed for review and are approved prior to first use; developing new processes and procedures; facilitating PARC/STRC Steering Committee meetings; and owning onboarding efforts as it pertains to PARC/STRC and Veeva.
ESSENTIAL FUNCTIONS:Leads cross-coordination and prioritization efforts for all PARC/STRC jobs within the USEnsures regulatory compliance of promotional materials while effectively managing business riskEnsures all logistical and operational support teams and priorities are aligned across all areas of the business as it relates to commercial execution of promotional materials and messagingMonitors regulatory promotional environment by reviewing regulatory promotional guidelines and untitled warning letters to companies published by regulatory agencies.Manages activities related to promotion and advertising including maintenance and preparation for electronic submission of promotional materials to regulatory agencies.Leads the effort, with brand team members and agencies, to develop review timelines and ensures materials are submitted following submission guidelines; proactively identifying discrepancies and resolving submission errors prior to routing promotional materials for review and approval.Coordinates with internal and external partners to manage the overall workflow, process and documentation through the internal review system in accordance with promotional review and approval (PARC), and sales training review and approval (STRC).Provides recommendations on phase IV clinical trial design with regard to marketing promotion possibilities of potential data/claims.Establishes and manages operational KPIs and develops associated PARC/STRC scorecards/reporting. Leads reporting and analytics regarding the review process, prioritization, label changes, launch initiatives, etc.Supports planning and preparation for monthly/Quarterly PARC Steering Committee meetings.Leads the team's training and onboarding as it relates to PARC/STRC and VeevaResponsible for oversight of the typesetting, printing, approval, and implementation of all promotional labelingLeads cross functional review team meetings with various levels of management, facilitates conversations which lead to resolution, proactively identifies gaps and potential issues, takes formal meetings notes, ensures proper documentation, and clearly identifies next steps for all reviews.Manages and coordinates material as it relates to a label change or product launch.Oversees all internal and external training on the process for promotional review and approval (PARC), and sales training review and approval (STRC).Oversees and provides direction on the inventory management of all promotional materials to ensure materials are warehoused, maintained, tracked and delivered within budget and are monitored for compliance.In conjunction with other Business Effectiveness stakeholders, develops long-term roadmap for the continued evolution of our CRM platform.Continuously looks for process improvements on current and future processes to allow for growth and continued efficiency.
REQUIRED EDUCATION, EXPERIENCE, and SKILLS:Accredited Bachelor's degree8+ years of direct experience in managing day-to-day responsibly of PRC/MRL processes in the pharmaceutical industryProficiency in Veeva PromoMatsExcellent organization and customer support skillsStrong verbal and written communication skills with ability to interface with all levels of Lundbeck employees, project teams, external partners, vendors, customers, agencies and affiliates.High level of attention to detailAbility to influence others to accept practices and approaches.Conflict resolution and negotiating skillsAbility to manage large projects and processes with limited oversight from managerCoaching, reviewing and delegating work individualsHighly proficient in managing multiple projects with varying degrees of complexity to timelinesWorking knowledge of FDA guidelines and laws which govern advertising and promotion in the pharmaceutical industry
PREFERRED EDUCATION, EXPERIENCE, and SKILLS:Veeva PromoMats Admin experience strongly preferredPharmaceutical marketing or sales experience preferredCross functional project management experience specifically related to promotional materials in a regulated industryExperience working within a commercial organizationExperience typesetting and implementing labeling into promotional materialsAt least 3 years of people management experience (contractor or FTE)
TRAVEL:Willingness/Ability to travel up to 10% domestically. If based remotely, additional travel will be required to Deerfield, IL. International travel may be required.
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $170,000 - $200,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site . Applications accepted on an ongoing basis.
#LI-Remote #LI-CP1
Why Lundbeck
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site .
Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site .
Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify .
About Lundbeck
Lundbeck is a biopharmaceutical company focused exclusively on neuroscience, with more than 70 years of experience in improving the lives of people with neurological and psychiatric diseases.
As a focused innovator, we strive for our research and development programs to tackle some of the most complex challenges. We develop transformative medicines targeting people for whom there are few, if any, treatment options.
Our goal is to create long-term value and make a positive contribution to people and societies, everywhere we operate. We are committed to fighting stigma and discrimination, and we act to improve health equity for the people we serve and the communities we are part of.
.video-container{ display: flex; flex-direction: row; /* Set flex-direction to row */ max-width: 1200px; padding-top: 20px; } .column { flex: 1 1 30%; margin-right: 20px; } .column:last-child { flex: 1 1 70%; /* Adjust the last column to 60% width */ margin-right: 0; } /* Styles for desktop screens */ @media (min-width: 1200px) { .inner iframe { width: 420px; height: 235px; padding-top: 5px; }}
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