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$178.5k - $257.83k
...working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR)Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols,...SuggestedFull timeLocal area- ...executing checks and balances. Regulatory & Compliance — Ensure programmatic plans, targeting parameters and placements comply with FDA/OPDP guidance, client Medical/Legal/Regulatory (MLR) requirements and platform-specific healthcare advertising policies (e.g., Google,...SuggestedLocal area
$243.59k - $365.38k
...clinical development and/or post-approval medical affairs.Well-developed insight into the US regulatory environment, including FDA and OPDP.Excellent scientific communication, presentation, and customer engagement skills.Ability to travel 25% on average within the US and...SuggestedFull timeTemporary workWork at officeFlexible hours3 days per week$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 all components...SuggestedHourly payFull timeFreelanceRemote work$90k - $95.5k
...involving Commercial, Medical, Regulatory, Legal, and Compliance stakeholders. Familiarity with FDA advertising and promotion regulations, OPDP considerations, and promotional material lifecycle management. Demonstrated ability to manage multiple projects, stakeholders, and...SuggestedFull timeWork at office- ...environment. Substantial understanding of relevant therapeutic area required. Good understanding of legal and regulatory guidelines (e.g. OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals). Good understanding of Good Clinical Practices, ICH...Suggested
$50 - $67 per hour
...agency Direct experience managing pharma promotional content through MLR review Working knowledge of Veeva Vault PromoMats and FDA/OPDP requirements for branded and unbranded materials Proven ability to manage multiple projects and stakeholders at once Comfort working...Suggested- ...execute omnichannel promotional strategy. Develop and track KPIs across launch phases; ensure cross-functional execution alignment. Lead OPDP submission planning/execution for launch. Identify and execute opportunities to optimize the customer experience and develop a...Suggested
$120k - $180k
...accurate, and appropriately archived. Serve as an operational expert for Veeva Vault PromoMats or equivalent review platforms. Facilitate OPDP submission requirements and related documentation needs, as applicable. Lead quarterly business reviews for assigned CRC team(s),...SuggestedSummer workRemote workFlexible hours2 days per week$55.16 - $61.29 per hour
...promotional materials through the medical, legal, and regulatory (MLR) review process Working knowledge of Veeva Vault PromoMats and FDA/OPDP regulatory guidelines for branded and unbranded content Proven track record of managing multiple complex projects and cross-...SuggestedHourly payTemporary workWork experience placement- ...to ensure potential issues are resolved for overall achievement of deadlines (Regulatory Affairs return of jobs, 2253 submission to OPDP, etc.). Collaborate with Marketing Operations, BTS and Brand to provide feedback and support for process and system enhancements. Associate...SuggestedTemporary workLocal areaRemote workShift work
$139.6k - $219.7k
...leadership 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...SuggestedLocal areaFlexible hours3 days per week$217.6k - $256k
...teams supporting marketed products. Strong knowledge of FDA regulations governing pharmaceutical advertising and promotion, including OPDP requirements, promotional guidance documents, and enforcement actions. Ability to interpret complex regulatory requirements and...Suggested- ...tooling, or reporting systems. Solid understanding of pharmaceutical advertising regulations and compliance requirements (e.g., FDA, OPDP guidelines, MLR review processes). Familiarity with data privacy frameworks relevant to healthcare advertising (HIPAA, NAI, and...SuggestedRelocation packageFlexible hours
- ...%)Archiving/closeout of submission sequences (20%)Archives HA correspondence (including emails, letters, faxes, contact reports and OPDP submissions) in US archive and EDMS (15%)Supports document retrieval as requested (electronic and paper); Supports inspections re: document...SuggestedRemote work
- ...PRODUCTS W, X, Y, Z: clinical profile, formulation, RTU advantages, formulary status, and competitive landscape Deliver only FDA/OPDP-approved promotional materials and messaging all content must be PRC-approved before use Adhere to all PAR Health compliance policies...Local areaWeekend workAfternoon shift
- ...Help ensure outbound communications remain truthful, balanced, accurate, appropriately substantiated, and aligned with applicable FDA/OPDP expectations, 21 CFR Part 202 requirements, approved labeling, company policies, and relevant industry standards Develop, maintain,...
- ...US promotion; translate insights into clear guidance for US stakeholders. External Agency Engagement: Serve as primary liaison with OPDP/APLB for assigned brands; manage requests for FDA advisory review, address enforcement actions, and adjudicate incoming/outgoing competitor...Work at officeFlexible hours3 days per week
$84.19k - $115k
...Veeva PromoMats), Advertising & Promotional Review in the pharmaceutical or biologics industry Working knowledge of FDA regulations, OPDP or CBER guidelines, and pharmaceutical biologics/marketing compliance Proficiency in Adobe Acrobat, MS Word, MS Excel, MS PowerPoint...Remote workFlexible hours$10 per hour
...and/or portfolio team management of $10-20M in brand revenue Pharmaceutical ad agency experience with launch, med/legal and FDA 2253/OPDP submission experience Desired Requirements: BA/PMP certification Finance: Proficiency developing scopes, estimates, and weekly...Flexible hours- ...medical and regulatory expertise: Strong understanding of life sciences marketing, medical affairs, and regulatory compliance (e.g., FDA, OPDP, MLR review). Editorial precision: Exceptional ability to analyze scientific and clinical content, detect inaccuracies, and ensure...
- ...acumen with HCP, U.S. and global experience Experience supporting brand launches and commercialization Strong understanding of MLR and OPDP requirements Ability to balance multiple priorities while keeping teams aligned and motivated Why This Opportunity? This is an...Contract work
- ...pharmaceutical promotional content through MLR review. ~ Working knowledge of Veeva Vault PromoMats, and an understanding of FDA/OPDP requirements for branded and unbranded materials. ~ Demonstrated ability to manage multiple projects and stakeholders simultaneously...Full timeContract workTemporary workWork at officeLocal areaMonday to Friday
$100k - $140k
...Medical Review Committees. Provides oversight of submission of promotional materials to the FDA’s Office of Prescription Drug Promotion (OPDP) and Advertising and Promotional Labeling Branch (APLB). Serves as the subject matter expert for Regulatory Affairs to the marketing...Full timeWork at officeVisa sponsorship- ...across media. You will partner with Commercial, Medical, Legal, and Regulatory teams to ensure scientific accuracy and adherence to FDA/OPDP, FTC, and PhRMA Code. The role requires 10+ years in pharma regulatory compliance focused on advertising and a strong background in...Fixed term contract
$128.6k - $210k
...professionals at co‑promote partner companies. Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP...Work at officeWorldwide- ...appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Canada Pharmaceutical Advertising Advisory Board (PAAB) and other regulatory considerations that may impact business. Develop or...Temporary workWork at officeFlexible hours
$43 per hour
...to ensure potential issues are resolved for overall achievement of deadlines (Regulatory Affairs return of jobs, 2253 submission to OPDP, etc.). Collaborate with Marketing Operations, BTS and Brand to provide feedback and support for process and system enhancements....Temporary workLocal areaRemote workShift workKelly Services
Irvine, CA17 days ago$166.72k - $250.08k
...and assess them for consistency with prescribing information, fair balance, risk communication, evidentiary support, and relevant FDA/OPDP expectations. Apply current laws, regulations, guidances, enforcement trends, and regulatory precedent to assigned reviews and...Work at office$160k - $190k
...low-code automation tools. Understanding of pharmaceutical promotional and medical communication compliance requirements (e.g., FDA OPDP guidance, PhRMA Code). Experience with project management or ticketing tools (e.g., Jira, ServiceNow, Azure DevOps). Please note: This...Work at officeImmediate startRemote work
