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$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- ...managing 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....SuggestedFull timeContract workTemporary workLocal areaMonday to Friday
$85k - $110k
...projects in a fast-paced agency environment Proficiency in Adobe Creative Cloud and working knowledge of pharma regulatory review (FDA, OPDP, PAAB, ASC); familiarity with AI-powered creative tools is a plus $85,000 - $110,000 a year Compensation & Benefits Full medical and...SuggestedRemote workHome officeFlexible hours- ...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...SuggestedLocal areaRemote 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...SuggestedInternshipLocal areaWeekend workAfternoon shift
$120k - $180k
..., 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), including...SuggestedSummer workRemote workFlexible hours2 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- ...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,...SuggestedLocal area
$85k - $110k
...projects in a fast-paced agency environment Proficiency in Adobe Creative Cloud and working knowledge of pharma regulatory review (FDA, OPDP, PAAB, ASC); familiarity with AI-powered creative tools is a plus $85,000 - $110,000 a year Compensation & Benefits Full medical...SuggestedRemote workHome officeFlexible hours$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- ...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...SuggestedContract work
$184k - $207k
...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,...SuggestedWork at officeLocal areaRemote work- ...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...Suggested
- ...rigorous medical, legal, and regulatory (MLR) review process. Working knowledge of Veeva Vault PromoMats and a solid understanding of FDA/OPDP regulatory guidelines for both branded and unbranded content. Proven track record of successfully managing multiple complex...Suggested
$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...SuggestedFull timeWork at officeVisa sponsorship$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$55k - $80k
...knowledge and experience to confirm brand style decisions. Builds and maintains a command of brand data and content. Helps enforce OPDP/regulatory guidelines. Helps to resolve content issues using reference materials and collaboration with copywriter. Supports copywriters...Full timeWork at officeLocal areaRemote workWeekend workAfternoon shift3 days per week$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
$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- ...Job Description Job Description Overview The Operating Partner Development Program (OPDP) is a comprehensive training experience designed to build the next generation of leaders for our company-owned retail stores. This program is for ambitious, self-starters...Relocation
- ...~ Regulatory & Compliance — Ensure tagging, pixel implementation and data collection/onboarding practices comply with HIPAA, FDA/OPDP guidance and platform-specific healthcare advertising policies; safeguard against inadvertent collection of protected health information...Local area
- ...Communications to enable compliant commercialization strategies across launch and lifecycle management. The VP will represent Amylyx with FDA OPDP, oversee promotional review, disease awareness communications, digital initiatives, and patient #J-18808-Ljbffr Amylyx...Remote job
$314k - $353k
...communications, and future pipeline assets. This individual will represent Amylyx with FDA’s Office of Prescription Drug Promotion (OPDP) and play a critical leadership role supporting the successful launch of avexitide and future commercial products. We anticipate hiring...Work at officeLocal areaRemote work- ...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 ~...Full timeWork at officeLocal areaFlexible hours
$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- ...fair balance, substantiation requirements, and risk mitigation. Manage all submissions to FDA Office of Prescription Drug Promotion (OPDP) and Advertising and Promotion Labeling Branch (APLB), including the timely and accurate FDA 2253 submissions of US promotional...Work at officeLocal area
- ...checks and balances. \n\n \n 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,...Local area
- ...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
- ...pre-clearance or notification, including Form FDA 2253 submissions in the United States. - Apply strong knowledge of FDA regulations, OPDP guidance, and requirements governing advertising and promotion of radiopharmaceutical products, escalating regulatory issues when...Full timeLocal area