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Part-time
bachelor degree, postgraduate degree
Posted 1d ago
~40 hrs/week
Responsibilities
The consultant will lead the regulatory role during Promotion Review Committee meetings to ensure promotional materials comply with FDA regulations. They are responsible for reviewing and approving promotional and non-promotional content while providing strategic regulatory guidance to marketing teams.
Requirements
Candidates must have at least 5 years of experience in the pharmaceutical or biotech industry with a focus on regulatory advertising and promotion. A bachelor's degree in a relevant field is required, with a PharmD being preferred.
Full job description
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
Providing compliant and accurate solutions from a regulatory affairs promotional and advertising review perspective - while providing marketing with competitive solutions for consumer, healthcare provider and managed care materials for all assigned brands.
Acting as lead for Regulatory role during Promotion Review Committee (PRC) meetings and overseeing the promotional review process, as well as other promotion related processes for assigned brands or therapeutic categories.
Reviewing Product launch, Growth brand, Established brand and Derivative materials for assigned projects.
Providing guidance on risk to the PRC and if need be, elevating the risk to their manager/line manager within the client.
Essential Functions
Review and approval of all promotional and non-promotional materials for assigned PRC with strong understanding of regulatory advertising and promotion regulations and FDA advertising and promotional Guidances.
Attend prioritization discussions for the assigned PRC.
Evaluate CFL (consistent with FDA-approved label) opportunities.
Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies.
Provide counsel to job owners on planning for the review process including timing considerations, type of review to consider, and guidance documents to review.
Communicate information provided during promotion review meetings to the broader regulatory team when appropriate.
Clarify rationale and represent regulatory comments on review materials during live PRC meetings.
Interact with Agency Partners and Regulatory/Regulatory Operations Managers for the submission of promotional materials to OPDP for initial use (Form FDA 2253).
Partner with job owners and other stakeholders in the execution of job reapprovals and tactics related to label changes for assigned brands.
Monitor US regulatory promotional environment by staying up-to-date on FDA regulations and guidances.
Review of untitled and warning letters to pharmaceutical companies issued by OPDP, APLB, Center for Devices and Radiological Health (CDRH), Federal Trade Commission (FTC), National Advertising Division (NAD) or other governing bodies.
As appropriate, attendance at major FDLI, DIA, and other industry/FDA meeting.
Necessary Skills and Abilities
Strong ability to work independently, with flexibility and a strong ability to connect and collaborate with clients and team members while working remotely.
Proven ability to provide strategic direction and innovative, forward thinking regulatory guidance and analyze and interpret efficacy and safety data.
Working knowledge of FDA and Pharmaceutical regulatory and compliance guidelines on advertising and promotion, including product launches.
Deep understanding of the advertising/creative development process.
Understanding of pharmaceutical review and approval process.
Experience in leading activities necessary for promotional OPDP submissions.
Experience with using new and social media platforms for promotion of prescription drugs in the US.
Proficiency in computer applications and configuration, including Microsoft Office, Adobe Acrobat. - Proficiency in Veeva Vault Promo Mats or other electronic review platforms.
Educational Requirements
A Bachelor’s degree is required, focus in Medical, Science, Marketing, Business or Communications; a PharmD is preferred.
Experience Requirements
5+ years of related experience in the pharmaceutical/ biotech industry is required. May consider related experience from healthcare advertising agency.
Functional experience in regulatory advertising and promotion required.
Previous experience in medical advertising and promotional review, marketing operations, sales or communications preferred.
Product launch or advertising agency account management experience is a plus.
Strong project and process management experience is required, in pharmaceutical industry is preferred.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.*
End-to-end bespoke solutions that de-risk & accelerate our partners' and sponsors' drug and device development programs
Industry
Business Consulting and Services
Company size
1,001-5,000 employees
Founded
2001
Headquarters
Raleigh, North Carolina
LinkedIn followers
203,289
Total funding
$9M
At ProPharma, we help pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market. From early development through clinical, regulatory approval, and commercialization, we provide expert guidance to navigate complex challenges and accelerate success.
Our mission is simple: improving patient health and safety by delivering the highest-quality regulatory, compliance, clinical research, pharmacovigilance, and medical information services throughout the entire product lifecycle.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risks and accelerates high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science!
Offices: 107 W Hargett St, Raleigh, North Carolina 27601, US · Olliver, Richmond, North Yorkshire DL10 5HX, GB · Schipholweg 59, P.O. Box 255, Leiden, AG 2316 ZL, NL · Siemensdamm 62, Berlin, Germany 13627, DE · Solnavägen 3H, 113 63 Stockholm, Sweden, Stockholm, Stockholm County SE -112, SE
How many Healthcare jobs are open in Raleigh, NC right now?
There are currently 1,798 open healthcare positions in Raleigh, NC listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Raleigh, NC?
Companies currently hiring include WakeMed, Duke University Hospital, PruittHealth, Duke University School of Medicine, ProPharma, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Raleigh, NC?
Yes — 318 of the 1798 open healthcare positions offer remote or hybrid work (100 remote, 218 hybrid).
How do I apply for Healthcare jobs in Raleigh, NC?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.