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$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...SuggestedLocal areaFlexible 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...SuggestedRemote workFlexible hours- ...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
$210k - $240k
...therapeutic guidelines, competitor landscape, and scientific data interpretation. Extensive understanding of FDA promotional regulations, OPDP standards, and medical-legal compliance. Excellent written and verbal communication skills with the ability to influence cross-...SuggestedFull timeTemporary workPart timeFlexible hours$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- ...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
- ...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
$210k - $257k
...compliance and regulatory frameworks governing scientific exchange. Deep understanding of U.S. regulatory requirements (e.g., FDA, OPDP) and industry standards (e.g., GPP, ICMJE, PhRMA Code). Exceptional communication, negotiation, and stakeholder management skills....SuggestedHourly payFull timeWorldwide$150.5k - $245.5k
...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$100.6k - $151k
...decision-making, or Health IT strategies Understanding of pharmaceutical marketing, FDA regulations, and compliance standards (e.g., OPDP, PhRMA guidelines). Familiarity with medical terminology and clinical trial processes. Experience with project management...SuggestedRemote jobFull time$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 hours- ...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,...SuggestedTemporary workLocal area
$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...SuggestedFull timeWork at officeLocal areaWorldwide$145.6k - $270.4k
...products on Materials Approval Process (“MAP”) teams. May include a launch product or indication with manager oversight. Liaison with OPDP regarding advertising and promotion for assigned products, including products approved under Subpart H with manager oversight....SuggestedLocal areaRemote workRelocation- ...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...Suggested
$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,...Full timeTemporary workFor contractorsLocal areaWorldwide- ...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
- ...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
- ...developing and executing strategies that not only ensure stringent compliance with global health authority regulations (e.g., FDA, MHRA, OPDP) but also maximize the commercial potential and competitive positioning of Azurity’s product portfolio. Key Strategic...Live inWork at officeWork from homeWorldwide
$280.56k - $350.7k
...medical based communications, congresses, and ad boards. Serve as primary contact leading and facilitating communications with the OPDP reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for...Full timeTemporary workWorldwideFlexible hoursShift workSumitomo Pharma
Sacramento, CA4 hours ago$280.56k - $350.7k
...compliance for medical communications, conferences, and ad boards. Serve as primary contact leading and facilitating communications with OPDP reviewers for advisory comments and negotiations regarding promotional claims for assigned products, including preclearance of...Full timeFlexible hoursShift workSumitomo Pharma
Honolulu, HI4 hours ago- ...manage multiple projects simultaneously, including market research, promotional tactics and message development, and associated PRC and OPDP processes ~ Track record of cross-functional collaboration ~ Willingness to travel up to 20% Preferred Qualifications...Full timeLocal area
Medium
Menlo Park, CA4 hours ago - ...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 employmentFull timeContract workWork at officeLocal areaRemote workRelocation packageFlexible hours
Chiesi Farmaceutici S.p.A.
Boston, MA4 hours 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...Full timeFreelanceWork at officeRemote workShift work3 days per week
Breaking Data
Cherry Hill, NJ3 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 crossfunctional process...Full timePart timeFor contractorsLocal area
Gilead Sciences, Inc.
Foster, CA4 hours ago $115 - $135 per hour
...supporting product launches and ongoing lifecycle management ~ Strong knowledge of FDA advertising and promotion regulations and OPDP submission processes ~ Understanding of FDA evidence standards for promotional claims and clinical data interpretation ~ Excellent...Contract workPart timeWork at officeRemote workYoh, A Day & Zimmermann Company
South San Francisco, CA1 day ago
