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$185k - $215k
...and submission of promotional and medical materials, as well as maintaining productive relationships with internal partners and FDA/OPDP. The position also leads or supports regulatory training initiatives and serves as a resource on advertising and promotion regulations...SuggestedWork at officeRemote workFlexible hoursLundbeck
Deerfield, IL27 days ago$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...SuggestedFull timeNight shift$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...SuggestedWork at officeLocal area$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$115k - $230k
...party 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 initiatives (formats, creative, audience, signals) tied to KPI...Suggested$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...SuggestedWork at officeLocal areaWorldwide- ...environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings. Ensures that changes in US Prescribing Information are...SuggestedContract workRemote 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 ~...SuggestedFull timeWork at officeLocal areaFlexible hours
- ...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...SuggestedFull timeNight shift
$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$500 per month
...relevant therapeutic area required. ~ Oncology & Hematology ~ 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,...SuggestedFull timeWork at officeLocal areaSynectics
Lake Forest, IL1 day ago$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...SuggestedLocal areaSanofi
Cambridge, MA2 days ago$206.25k - $297.92k
...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...SuggestedLocal areaSanofi Group
Cambridge, MA4 days ago$172.5k - $249.17k
...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...SuggestedSanofi
Cambridge, MA1 day ago- ..., websites, emails, banner ads, videos, social content) for pharma or biotech brands. ~ Familiarity with AMA Manual of Style, FDA/OPDP promotional guidance, and standard pharma MLR workflows. ~ Experience collaborating with design teams and recommending visual concepts...SuggestedFull timeFreelanceWork at officeRemote workShift work3 days per week
Breaking Data
Cherry Hill, NJ4 days ago - ...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...Full timePart timeFor contractorsLocal area
Gilead Sciences, Inc.
Foster, CA1 day ago
