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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$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$121k - $171k
...points Partner with product marketing, sales, and clinical teams to align messaging and tactics. Ensure all digital assets comply with OPDP guidelines, regulatory/legal requirements, and Edwards branding standards. Support congress and event strategies with digital...SuggestedWork experience placementWork at officeWorldwide- ...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
$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- ...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...SuggestedLocal area
- ...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
$5,000 per month
...solve problems, reach goals, encourage others and champion our brand. Overview: The Fleet Feet Operating Partner Development Program (OPDP) is an immersive training experience designed to develop successful, growth-oriented leaders into future Operating Partners of our...SuggestedFull timePart timeLocal areaImmediate startRelocation$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...SuggestedRemote 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
- ...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
$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- ...complex client programs from concept through execution. Deep familiarity with pharmaceutical regulatory processes, including MLR review, OPDP guidelines, and compliance workflows. Experience supporting brand launches and/or managing omnichannel campaign execution....SuggestedFull timeWork at officeRemote workWork from homeHome officeFlexible hours
$197.6k - $296.4k
..., middleware, and data orchestration.**Governance & Compliance*** Ensure all platform solutions meet regulatory requirements (e.g., OPDP, HIPAA, GDPR) and internal governance standards.* Establish technical guardrails and architectural governance models to balance innovation...SuggestedSummer workRemote workFlexible hours2 days per week$140k - $185k
...Commercial 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 (VaultPromomats), working directly...SuggestedFlexible hours2 days per week3 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$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...Full timeTemporary workFixed term contractLocal areaShift work$200k - $240k
...Committee (MRC) teams or other promotional review committees.* Serve as back-up contact with the FDA Office of Prescription Drug Promotion (OPDP).* Working with Regulatory Operations, assist with 2253 submissions.* Monitor competitor space advertising and promotion materials.*...Temporary workLocal areaImmediate start- ...regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR). * Lead the review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to...Local area
- ...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...Hourly payPermanent employmentContract workWork at officeLocal areaRemote workRelocation packageFlexible hours
- ...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
$150k - $225k
...promotion, and communication as applicable. Serving as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) and /or Advertising and Promotional Labeling Branch (APLB) for assigned products, including responsibilities for the timely...Temporary workWork at officeFlexible hours3 days per week- ...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
$175k - $205k
...input, as well as preparation and execution of branded promotional material submissions to the Office of Prescription Drug Promotion (OPDP) that are compliant with applicable laws and regulations, as required. Develops working relationships with OPDP staff as necessary...Summer workWork at officeLocal areaImmediate start$29 - $35 per hour
...stakeholders by contributing to key compliance, documentation, and process enhancement initiatives. With the recent heightened focus on OPDP (Office of Prescription Drug Promotion) enforcement, this role provides hands‑on exposure to how pharmaceutical promotional...InternshipWork at officeLocal area$162.8k - $244.2k
...standards.**Knowledge and Skills:*** Strong understanding of pharmaceutical marketing strategies, including creative campaign development, OPDP submissions, MLR reviews, omnichannel ecosystem planning, and patient journey mapping.* Excellent project management skills, with...Summer workRemote workFlexible hours2 days per week- ...Maintain up-to-date knowledge of applicable guidance, regulation, and law governing pharmaceutical functions (e.g., FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR). Oversee conduct of all clinical studies in adherence to company standards and government/industry regulations...
- ...sales materials (print and digital sales aids, videos, responsive websites, banner ads, email tools, etc) ~ Med/legal and FDA 2253/OPDP submission experience preferred ~ Microsoft Office Suite: Word, Project, Excel, PowerPoint; Acrobat Professional; web-based paperless...Full timeWork at officeLocal areaFlexible hours
$130k - $190k
..., and aligned with approved labeling and scientific evidence. Prepare and submit FDA Form 2253 filings; maintain records and track OPDP correspondence in conjunction with regulatory operations. Ensure alignment with promotional materials with CCDS, USPI/PI, IFU, and...- ...evidence 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. *...Full timeNight shift