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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- ...reporting discrepancies. Compliance, Platform Coordination & Operational Excellence Ensure all campaign activations align with FDA, OPDP, and internal MLR requirements. Validate URLs, landing pages, targeting parameters, budgets, and campaign flight dates prior to launch...Suggested
- Medical Editor • Adds reference annotations to final PDFs of promotional materials for OPDP submission • Highlights and back-annotates corresponding references for OPDP submission • Supplies missing reference annotations and/or references • Completes multiple projects...SuggestedWork experience placement
$195k - $225k
...a launch or commercial-stage setting, additional experience in patient/caregiver marketing preferred. Strong understanding of FDA/OPDP promotional guidelines, including consistent with FDA labeling (CFL) guidance, fair balance, and promotional review processes (MLR/PRC...SuggestedFlexible hours- ...collaboration style across functional areas; facilitate consensus across diverse perspectives Maintain current knowledge of FDA, OPDP and pharmaceutical regulatory guidelines REQUIRED QUALIFICATIONS Experience ~10-15+ years strategic leadership or consulting...SuggestedWork at officeRemote workShift work
$125k - $155k
...Review and mark up copy changes on layouts, as needed Work within the editorial process, leveraging client regulatory guidance and OPDP requirements for promotional tactics About You At least 7 years of combined copywriting experience in agency and pharmaceutical advertising...SuggestedAgency workSummer workImmediate startRemote workFlexible hours- ...all promotional materials to ensure they are accurate, balanced, medically and legally compliant, and aligned with industry and FDA/OPDP requirements before release. Manage the workflow, coordination between stakeholders, and ensure timely reviews and enhance the efficiency...SuggestedInternshipFlexible hours3 days per week
- ...position is highly desirable.* Work in Pharmaceuticals or regulatory driven marketing experience preferred.* Familiar with FDA guidelines, OPDP submissions and staying current on industry trends and regulatory guidelines are important.**Skills/Qualifications:*** Strong...SuggestedWork experience placementWork at office
$243.8k - $304.7k
...‑level understanding of the regulatory environment governing pharmaceutical advertising: HIPAA, HITECH, FDA promotional guidelines (OPDP), NAI health data standards, and state‑level health privacy laws. Technical fluency to engage credibly with engineering on API design...SuggestedFull timeTemporary workFixed term contractLocal areaShift work$200k - $260k
...to the needs of supported functions. Champion the Promotional Material medical, legal, regulatory (MLR) review process and support OPDP submissions. Manage the Digital content Management process - Digital Operations - marketing execution/websites/emails; including Print...SuggestedFlexible hours2 days per week3 days per week- ...approved marketing materials Track live and expired projects and ensure timely re-approvals Coordinate with regulatory to prepare OPDP submissions Onboard and train new PRC members, including external advertising agency partners Operations Secure exhibit space, sponsorships...Suggested
- ...as needed Work with outside advertising agencies on day-to-day operations (ensure accurate preparation of review materials including OPDP preclearance submissions, lead weekly status meetings, in collaboration with Client Production) Manage and execute promotional...Suggested
- ...management, capturing decisions/actions, and driving to consensus. Regulatory & Compliance Awareness: alignment to approved labeling; OPDP considerations; market-specific rules (e.g., EU member states). Document Quality: proofing, consistency checks, and readiness for...SuggestedLocal area
- ...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...SuggestedWork at officeFlexible hours3 days per week
- ...sales aids, websites, social media, videos, speaker materials). Ensure materials comply with FDA regulations (e.g., FD&C Act, 21 CFR), OPDP guidance, and internal SOPs. Assess claims for accuracy, balance, substantiation, and appropriate risk disclosure. Identify and...SuggestedWorldwideFlexible hours
$93.6k - $156k
...compliant with regulatory standards and Pfizer internal policies. The Manager may interact with the Office of Prescription Drug Promotion (OPDP) or the Advertising and Promotional Labeling Branch (APLB) on routine matters, under the direction of more senior personnel. The...Permanent employmentH1bWork at officeLocal areaVisa sponsorshipWork visaRelocation package2 days per week$150k - $160k
...programmatic, email, content syndication). Strong understanding of regulatory requirements for promotional digital content in pharma (FDA, OPDP, PhRMA guidelines), with experience navigating MLR processes. Understanding of common digital marketing tools and platforms (e.g.,...Full timeLocal area$140k - $185k
...Operations. Responsibilities: Champion the promotional materials medical, legal, regulatory (MLR) review process and support OPDP submissions; manage PRC SOP, meeting schedule, and plan / master tracker. Manage PRC platform (Vault Promomats), working directly...Flexible hours2 days per week3 days per week- ...such as Salesforce Marketing Cloud, Tealium CDP and Acquia Web.* Strong understanding of pharma/life sciences compliance requirements (OPDP, HIPAA, GDPR, 21 CFR Part 11).* Hands-on experience with Agile delivery and managing offshore development teams.* Proven experience...Work experience placementSummer workRemote work2 days per week
$222.4k - $278k
...execution. This role also facilitates risk identification and mitigation strategies, as well as oversees regulatory interactions with OPDP/APLB. The Senior Director develops and maintains a Performance Culture through building and sustaining high performing teams...Permanent employmentContract workWork at officeLocal areaRemote workFlexible hoursShift work- ...experience 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,...Temporary workLocal area
$187k - $300k
...Commercial, and other cross-functional stakeholders to accomplish company goals. Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential Functions Provide strategic guidance...Local areaFlexible hours- ...and engagement strategy, search marketing, email marketing, and CRM platforms preferred ~ Product launch, med/legal, and FDA 2253/OPDP submission experience ~ Microsoft Office Suite: Word, Project, Excel, PowerPoint; Acrobat Professional; web-based routing and...Work at officeFlexible hours
- ...Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global...Local area
$210k - $230k
...promotional plan development Responsible for leading interactions and 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 office$180k - $240k
...compliance status, risks, and mitigation progress across U.S. regulatory areas, including but not limited to Medical Information / OPDP, DSCSA, and state-level compliance. Act as a key advisor to the CEO and executive leadership by providing clear visibility into compliance...Night shift$126.11k - $152.81k
...Build a strong relationship with internal customers; including Commercial, Legal and Medical. Begin to develop relationships with OPDP. Prepare communications with guidance for OPDP concerning sub part e and advisory submissions. Ensure timely and accurate...Hourly payPermanent employmentFull timeTemporary workPart timeFor contractorsFixed term contractSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$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...Full timeLocal areaFlexible hours3 days per week$260k - $290k
...including regulatory review and approval of U.S. promotional, corporate, and medical communications of assigned brand(s), submission to FDA OPDP/APLB, and be the owner of the Sobi Global Material review process. The role is responsible for leading interactions with the FDA...Temporary workWork experience placementSummer workWork at office- ...medical affairs role Essential Skills and Abilities Must have a working understanding of legal and regulatory guidelines (e.g., OPDP promotional regulations, Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and...Temporary workWork at officeLocal areaRemote work