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- ...manage multiple projects simultaneously, including market research, promotional tactics and message development, and associated PRC and OPDP processes ~ Track record of cross-functional collaboration ~ Willingness to travel up to 20% Preferred Qualifications...SuggestedRemote jobFull timeLocal area
$80k - $95k
...Marketing, this role ensures timely and accurate submission of promotional materials to the FDA's Office of Prescription Drug Promotion (OPDP). The specialist will also coordinate onboarding and offboarding of sales representatives as it relates to support of speaker...SuggestedWork at officeHome officeFlexible hours$183.2k - $229k
...on review of promotional and non‑promotional materials and act as the liaison with the FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). Provide strategic regulatory input on promotional materials to ensure compliance...SuggestedWork at officeFlexible hours$139.6k - $219.7k
...of customer-facing teams to ensure executional alignment against strategic imperatives. Lead the planning and execution of an OPDP submission for launch. Identify opportunities to optimize the customer experience and lead the customer experience roadmap development...SuggestedFull timeLocal areaFlexible hours3 days per week- ...Rare Disease experience preferred Product launch experience highly preferred Digital marketing experience preferred Experience with OPDP and FDA requirements Solutions-oriented, strong analytical and presentation skills Creative, innovative, problem-solving approach...SuggestedHourly payPermanent employmentContract workWork at officeLocal areaRemote workRelocation packageFlexible hours
$210k - $240k
...therapeutic guidelines, competitor landscape, and scientific data interpretation. Extensive understanding of FDA promotional regulations, OPDP standards, and medical-legal compliance. Excellent written and verbal communication skills with the ability to influence cross-...SuggestedFull timeTemporary workPart timeFlexible hours- ...and approve or co‑review/approve promotional materials. You may manage external operational contractor support, including advising on OPDP submission requirements for accelerated approval and launch submissions, as applicable. You may initiate and/or contribute to local...SuggestedFor contractorsLocal areaFlexible hours
$302.01k - $390.83k
...Knowledge and experience in rare disease or liver disease preferred ~ Proven experience with pharmaceutical regulatory requirements (OPDP) and impact on development of marketing materials in accelerated approval ~ Excellent interpersonal skills with ability to lead,...SuggestedFull timeTemporary workFor contractorsLocal areaWorldwide$166k - $203k
...impacting potential US product promotion and is responsible for leading interactions with the FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB) pertinent to assigned brand(s). The individual will be responsible for all...SuggestedFull timeWork at officeLocal areaWorldwide$145.6k - $270.4k
...products on Materials Approval Process (“MAP”) teams. May include a launch product or indication with manager oversight. Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with manager oversight....SuggestedLocal areaRemote workRelocation- ...methodologies ~ Experience managing $4-6M pharmaceutical brand teams in an agency environment ~ Product launch, med/legal, and FDA 2253/OPDP submission experience ~ Skilled and seasoned with web development projects, life cycle management, analytics, and ~ strategy ~...SuggestedFull timeWork at officeLocal areaFlexible hours
- ...Knowledge and experience in rare disease or liver disease preferred* Proven experience with pharmaceutical regulatory requirements (OPDP) and impact on development of marketing materials in accelerated approval* Excellent interpersonal skills with ability to lead, interact...Suggested
- ...enforcement actions with regards to advertising and promotion of pharmaceutical products. Serves as regulatory liaison to FDA/CDER/OPDP or FDA/CBER/APLB for assigned products, with managerial oversight, as appropriate. May lead local cross‑functional process improvements...SuggestedFull timePart timeFor contractorsLocal area
- ...regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR).* Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry...Suggested
- ...enforcement which may impact the Company’s promotional activities.Manage interaction with the Office of Prescription Drug Promotion OPDP including response to regulatory inquiries, preparation of submissions for advisory comments, and timely preparation and submission...SuggestedWork at officeLocal areaFlexible hoursNight shift
- ...advice, support the resolution of FDA action letters, and lead company interactions with FDA Office of Prescription Drug Promotion (OPDP) and other health authorities. Ensure consistency with prescribing information and safety information Ensure standardization of defined...Work at officeRemote work
- ...to guide risk-based decisions, represent the company in regulatory interactions (e.g., FDA’s Office of Prescription Drug Promotion (OPDP)), and drive high-quality processes and metrics.Key Responsibilities* Develop and lead the global regulatory advertising & promotion...Work at office
$135k - $155k
...creative culture of the department. Operational & Industry Awareness Maintain a strong understanding of therapeutic areas, FDA/OPDP regulations, and industry trends. Demonstrate expertise in writing for both HCP and patient audiences. Stay current on...Remote jobFull timeImmediate startFlexible hours- ...required Essential Skills and Abilities Should have a good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals). Good understanding of Good Clinical Practices,...Full timeTemporary workLocal area
$99.3k - $198.7k
...Abbott . Operations PDP participants rotate through one year assignments over the course of three years . The Manager, OPDP Americas , will be the primary liaison for Americas Operations PDP. This role is responsible for overseeing all aspects of the...Full timeWorldwide$115k - $230k
...and privacy-preserving activation; improve audience quality and efficiency. • Establish compliant operating norms aligned to FDA/OPDP and platform policies; ensure auditability. • Lead test-and-learn (formats, creative, audience, signals) tied to KPI ladders and...$168.1k - $268.7k
...regulatory frameworks governing scientific exchange. • Deep understanding of U.S. regulatory requirements (e.g., FDA, OPDP) and industry standards (e.g., GPP, ICMJE, PhRMA Code). • Exceptional communication, negotiation, and stakeholder...Hourly payWorldwide$35 - $45 per hour
...Verify adherence to client?specific style guides, AMA Manual of Style (current edition), and required regulatory guidelines (FDA, OPDP, etc.). Check for errors in spelling, grammar, punctuation, word usage, formatting consistency, and visual layout. Scrutinize...Hourly payFull timeFreelanceRemote workClutch
California, MO3 days ago$280.56k - $350.7k
...for medical based communications, congresses, and ad boards Serve as primary contact leading and facilitating communications with OPDP reviewers regarding promotional claims for assigned products, including pre-clearance of launch materials Direct and ensure the...Full timeTemporary workWorldwideFlexible hoursSumitomo Pharma
Denver, CO6 days ago$280.56k - $350.7k
...compliance for medical communications, conferences, and ad boards. Serve as primary contact leading and facilitating communications with OPDP reviewers for advisory comments and negotiations regarding promotional claims for assigned products, including preclearance of...Full timeFlexible hoursShift workSumitomo Pharma
Providence, RI6 days ago$127.5k - $187k
...of Paid, Earned, Shared, Owned media channels and planning. Experience with regulatory compliance in creative production (e.g., OPDP, FDA submissions). Demonstrated leadership, collaboration, and influence across agencies and peer groups. Strong communication...Full timeWork at officeWork visaFlexible hoursEli Lilly
Indianapolis, IN16 hours ago- ...generation, and US Medical Affairs principles. Deep knowledge of relevant regulatory and compliance frameworks (PhRMA Code, FDA/OPDP guidance, HCP interaction standards, SOPs). Proven ability to communicate complex scientific data clearly and credibly. Demonstrated...Full timePart timeNight shift
BESTMSLs
Los Angeles, CA6 days ago
