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Associate Director Advertising and Promotion Compliance - Remote opportunity

Employer
Lundbeck
Location
Working From Home
Start date
Mar 16, 2023

View more

Discipline
Marketing, Advertising, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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!

 

Open to candidates anywhere in the greater United States - Preferably based in the East Coast or Midwest

 

SUMMARY:

Under the supervision of departmental management, the Associate Director, Advertising and Promotion, Strategy and Compliance (US RA): provides regulatory advertising and promotional direction for the successful launch and lifecycle management (LCM) of Lundbeck US drug products; helps ensure compliance with regulatory requirements and corporate standards; and maintains positive communications with internal commercial partners and FDA contacts. More specifically, this position provides regulatory label strategic direction and promotional guidance to internal business partners in order to facilitate the commercial brand plan, including executing the regulatory review, approval, and submission of advertising and promotional materials to ensure consistency with product labeling, current FDA regulations, guidance documents and internal SOPs.  This role is responsible to lead and/or help to facilitate departmental regulatory training initiatives both internal and external and provide research and communication concerning advertising and promotion regulations.

 

ESSENTIAL FUNCTIONS:

  • Provides regulatory review of product labeling, advertising and promotional materials for accuracy and compliance with FDA regulations. Manages, reviews and represents regulatory perspective at PARC meetings to negotiate accurate, compliant and competitive final materials. Identifies risk, problem-solves, offers solutions. Manages/supports related FDA submission activities in compliance with current FDA regulations.
  • In close cooperation with regulatory agents, coordinates regulatory promotional submissions; prepares submissions in compliance with regulatory requirements and guidance documents; ensures that appropriate review and approval is obtained.
  • Provides Regulatory strategic guidance on new concepts, DTC advisory processes, Consistent with FDA Label tactics, and Payor Communications in order to identify and mitigate risk.
  • Provides Regulatory leadership on brand and life cycle management teams, process optimization efforts, development and collection of metrics, and further enhancement of cross functional interactions.
  • Provides internal and external training on departmental initiatives and for compliance purposes. 
  • Monitors the external regulatory climate to inform internal customers of potential impact on long-term objectives; Represents RA at cross-functional team meetings to represent agreed-upon RA positions.
  • Develops and facilitates improvement efforts for internal promotional material review processes, through cross functional collaboration and leadership through influence, in order to support necessary compliance enhancements and departmental efficiencies.

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor's of Science Degree
  • 8+ years of experience in Regulatory, R&D or related area within the pharmaceutical, medical device or biotech industry with at least 4 of those years within either advertising/promotion or Regulatory experience specific to neurology, migraine, or biologics
  • Well versed in FDA Promotional Regulations, and specifically experience in the review and interpretation of materials directed to professional and direct to consumer audience.
  • Experience in the review of technical content and assessment of product claim feasibility, in alignment with guidance associated with the communication of health care economic information and data analysis for consistent with label usage.
  • Expertise in navigating FDA interactions, including experience with FDA negotiations and/or OPDP communications.
  • Demonstrated proficiency in following scientific arguments, well-established understanding of scientific data and promotional regulations as they relate to drugs and/or biologics
  • Proficiency in identifying regulatory risk and negotiating/resolving differences
  • Demonstrated leadership capabilities, both with direct reports, as well as leading by influence
  • Attention to detail and strong organizational skills with the ability to meet multiple deadlines
  • Demonstrated ability to work in a multi-disciplinary team
  • Excellent oral and written communication skills, including ability to articulate regulatory positions
  • High proficiency in MS Word, MS Excel and Adobe Acrobat      
  • Proficient in Veeva or comparable document management system
  • High Proficiency in time management and demonstrated ability to work independently        
  • 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 BS Degree in Science, Chemistry, Pharmacy or related subject study/experience
  • Knowledge in the Regulatory support of both biologics and small molecules
  • Degree in a Science Field (Ph.D., PharmD)
  • Experience in creation and launch of DTC campaign materials, including television commercials, social media, and/or patient and advocacy materials is beneficial.

 

TRAVEL

  • Willingness/Ability to travel ~10%+ domestically or internationally to business meetings and learning experiences.

 

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: $160,000 - $195,000 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.  

 

#LI-Remote, #LI-LM1

 

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.

Company

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

Offices in:

  • Deerfield, IL - Lundbeck US Home Office
  • LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
  • Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc

Diversity

Diversity matters, and inclusion creates powerful organizations

To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences but because of them. We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to D&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure D&I is an integrated practice and mindset.

Benefits

Lundbeck offers a competitive benefits package that includes:

• Medical, dental, vision effective day 1 of employment

• Generous vacation, sick leave, holiday shut down and company paid holidays

• 401k match with immediate vesting

• Parental Leave

• Hybrid work model for office-based roles

To view more details about our Benefits, please click on the link below.

Lundbeck 2023 Benefits Summary

Sustainable Development Goals

In 2020, we based the key aspects of our sustainability strategy on the UN Sustainable Development Goals (SDGs). We found we have a significant impact on seven of the 17 Goals:

• Goal 3: Good Health and Well-being

• Goal 5: Gender Equality

• Goal 8: Decent Work and Economic Growth

• Goal 10: Reduced Inequalities

• Goal 12: Responsible Consumption and Production

• Goal 13: Climate Action

• Goal 16: Peace, Justice, and Strong Institutions

Key examples are Goal 3 that is closely linked to our corporate purpose and dedication to restore brain health and Goal 13 that drives our efforts to prepare for a zero emissions future. We will use our influence and act to promote Goals 5, 8, 12 and 16. Across our sustainability actions, we are seeking partnerships with others to enable change and maximize impact (Goal 17).

Lundbeck

Who We Are

A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.

What We Strive For

Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.

What Drives Us

A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.

Our Societal Commitment

We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.

Our Investment in You

As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.

Employee Satisfaction

The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.

Employee

Our Beliefs

• Patient-driven We put patients at the center of our fight for health and human dignity.

• Courageous We dare to confront unsolved healthcare challenges.

• Ambitious We set high expectations for ourselves because people in need have high expectations of us.

• Passionate We persist in developing life-changing therapies because life should not be interrupted by brain disease.

• Responsible We act with respect and integrity in everything we do

   

CONNECT

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Company info
Website
Phone
224-507-1000
Location
6 Parkway North
Deerfield
Illinois
60015
United States

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