Share this Job

Senior Associate Approvals Process

 
Requisition ID:  3991
Location: 

Deerfield, Illinois, US

Date:  Jan 25, 2023
 

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: 

The purpose of the Sr. Associate, Approval Process position within Commercial Operations is responsible for leading the approval process for all promotional materials through the Medical, Regulatory, Legal review This position will ensure all promotional materials are reviewed and approved in a timely manner in accordance with all internal processes and procedures, including (but not limited to); facilitating cross functional team meetings with various levels  of management; managing promotional items through label updates; ensuring materials are routed for review and approved prior to first use; developing new processes and procedures; leading brand team status meetings to ensure compliant and timely approval; and training internal and external stakeholders on the process.

 

 ESSENTIAL FUNCTIONS:

  • Coordinate and facilitate effective and efficient PARC (promotional review and approval ) /STRC (sales training review) and approval (STRC) and Status meetings, managing the needs of cross-functional stakeholders
  • Drive planning, forecasting, and prioritization of key initiatives/materials to ensure timely approval of promotional materials.
  • Acts as liaison between all functional areas with a high sense of customer collaboration and to ensure all projects are completed accurately, timely and in compliance with all related requirements.
  • Leads the effort, with brand team members and agencies, to develop review timelines.
  • Ensures materials are submitted following submission guidelines; proactively identifying discrepancies and resolving submission errors prior to routing promotional materials for review and approval. 
  • Communicate timely and accurate information regarding project progress across functional teams in order to meet timeline and quality standards.
  • 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).
  • Leads 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. Leads cross functional meetings. Creates and maintains master promotional item list. Ensures timelines are met, etc.
  • Owns and manages all internal and external training on the process for promotional review and approval (PARC), and sales training review and approval (STRC).
  • Establishes strong relationships cross functionally, and with third party vendors and agencies, to foster collaboration in the review process.
  • Provides strategic direction and support in the development of new promotional materials as it relates to the approval process, production, warehousing and distribution. 
  • Executes typesetting, approval and implementation of all promotional labeling.  
  • Continuously looks for process improvements on current and future processes to allow for growth and continued efficiency.
  • Provides reporting and analytics regarding the review process, prioritization, label changes, launch initiatives, and ad hoc as requested.
  • Quickly assess critical situations and identify issue resolution
  • Exhibits a high degree of cross-functional customer service and relationship building abilities
  • Utilize metrics and reporting to drive improvement in quality, volume, and cycle time.
  • Lead and participate in the onboarding and PARC/STRC training of internal and external stakeholders

 

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited Bachelor’s degree and a minimum 3 years of direct experience in managing day-to-day responsibly of PRC/MRL process or similar regulated process review in the healthcare industry or related agency experience supporting the pharmaceutical industry
  • OR High School Diploma/GED and a minimum 5 years of direct experience in managing day-to-day responsibility of PRC/MRL process or similar regulated process review in the healthcare industry or related agency experience supporting the pharmaceutical industry
  • Demonstrate critical, creative thinking and problem-solving skills
  • Ability to produce clear and concise written and verbal communications.
  • Excellent organization and customer support skills
  • Strong verbal and written communication skills with ability to interface with all levels of Lundbeck employees, project teams, external partners, vendors, customers, agencies, and affiliates.
  • Excellent computer skills (Word, Excel, PowerPoint, Adobe), organizational skills and customer service orientation
  • High level of attention to detail
  • Ability to work independently as well as part of a team and to produce quality work under deadline pressure
  • Experience working with cross-functional groups and teams to achieve common goals
  • Ability to prioritize and multi-task to enhance productivity and manage workload in a fast-paced and rapidly changing environment.
  • Basic understanding of FDA guidelines and laws which govern advertising and promotion in the pharmaceutical industry
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation.

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited Bachelor’s degree strongly preferred
  • Prior Veeva PromoMats experience strongly preferred
  • Cross functional project management experience specifically related to promotional materials in a regulated industry
  • Experience working within a commercial organization
  • Experience typesetting and implementing labeling into promotional materials
  • Conflict resolution and negotiating skills

 

TRAVEL

 

  • Willingness/Ability to travel up to 25% domestically. International travel may be required.

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

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

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck  and via LinkedIn