Director Regulatory Advertising and Promotion
Princeton, NJ 
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Posted 6 days ago
Job Description

Please note that this position is based in Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.

Responsible for directing the regulatory aspects of internal and external communications including advertising and promotional activities as well as facilitation of labeling development, maintenance and distribution for all Acadia products. Coordinates the development and implementation of regulatory strategies for promotion and advertising plans and is a leader in the Medical, Legal and Regulatory Review process to support approval and dissemination of marketed product and disease state promotional material. Liaises with FDAs Office of Prescription Drug Promotion (OPDP) for Advertising and Promotion submissions and works with development teams as concerns the construct of proposed labeling for regulatory submissions according to product data and Acadia objectives.

Primary Responsibilities

  • Leads the development and oversight of the processes and procedures relevant to the creation, review and approval of advertising and promotional materials as part of Acadia Medical, Legal and Regulatory review process and other external communication to ensure regulatory compliance.
  • Reviews external communications materials, sales and marketing materials, including training, for compliance to current regulations and guidance.
  • Represents the regulatory department with senior management on regulatory strategy and risk analysis as it relates to Acadia's commercial strategy and compliance.
  • Participates in training for sales and marketing on advertising and promotional material.
  • Represents the company to outside customers and agencies and makes presentations as needed on current regulatory issues pertaining to advertising and promotional activities.

Education/Experience/Skills

Bachelor's degree in a scientific discipline or related field. MBA preferred. Targeting 10 years progressively responsible Regulatory Affairs experience with a focus on advertising and promotional regulations. An equivalent combination of relevant education and experience may be considered.

Key Skills:

  • Experience communicating and negotiating directly with OPDP and performing risk assessment.
  • Significant demonstrated experience developing and executing complex and innovative global regulatory strategies, assessing & communicating risk/benefit to senior management, and influencing organizational direction as it pertains to compliance advertising and promotion materials.
  • Experience with labeling development and life-cycle management
  • Experience involving complex negotiations with regulatory authorities.
  • Experience in organizational management, including matrix management of senior professionals and higher-level project teams.
  • Thorough knowledge of US and international regulations as they apply to pharmaceutical drug development.
  • Demonstrated problem solving abilities and conflict resolution skills.
  • Excellent verbal and written organizational and communication skills; Experience influencing and communicating policy issues.
  • Excellent transverse collaboration skills, demonstrated ability to work effectively in cross-functional and/or global teams.
  • Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the organization.
  • Proficient at creating and communicating a clear vision among team members effectively aligning resources and activities to achieve functional area and/or organizational goals.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.

#LI-EJ1 #LI-HYBRID

What we offer you (US-Based Employees):

  • Competitive base, bonus, new hire and ongoing equity packages
  • Medical, dental, and vision insurance
  • 401(k) Plan with a fully vested company match 1:1 up to 5%
  • Employee Stock Purchase Plan with a 2-year purchase price lock-in
  • 15+ vacation days
  • 14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
  • 10 days of paid sick time
  • Paid parental leave
  • Tuition assistance

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every single one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply - especially if the reason you are the best candidate isn't exactly as we describe it here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our or contact us at or .

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

Notice for California Applicants: Please within our Privacy Policy.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. ("Acadia"). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in absence of an executed search agreement will not obligate Acadia in any way with the respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.


ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
10+ years
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