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$176.66k - $229.43k
...BLAs, and post-approval submissions, including participation in MLR/PRC review processes Strong knowledge of FDA labeling regulations, OPDP requirements, and promotional review guidance Experience with commercial-stage products; immunology or biologics background...Suggested$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 protocols,...SuggestedFull timeLocal area$154.5k - $226.6k
...TA; ensure partners pull through the approach to consumer segments, channels (PESO), and content strategy; and represent the TA in OPDP processes.• Lead execution of Activation & Engagement efforts beyond core campaigns as well as derivations of core campaign tactics....SuggestedFull timeH1bLocal areaRemote workVisa sponsorshipWork visaFlexible hours- ...communications in a regulated environment (FDA, pharma/biotech). Working knowledge of pharmaceutical promotional regulations (e.g., FDA OPDP), pre-approval communications constraints, the distinction between promotional and non-promotional content, and MLR (Medical, Legal,...SuggestedFull timeWork at officeLocal areaRemote workWeekend workAfternoon shift
- ...therapies, or a closely related therapeutic area.Strong understanding of the US regulatory and compliance environment, including FDA and OPDP requirements, the PhRMA Code, and applicable Medical Affairs standards.Demonstrated ability to engage with and influence senior...SuggestedHourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week
- ...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...SuggestedTemporary workWork at officeFlexible hours
$120k - $170k
...tooling, or reporting systems. Solid understanding of pharmaceutical advertising regulations and compliance requirements (e.g., FDA, OPDP guidelines, MLR review processes). Familiarity with data privacy frameworks relevant to healthcare advertising (HIPAA, NAI, and...SuggestedH1bVisa sponsorshipRelocation packageFlexible hours$139.6k - $219.7k
...leadership 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...SuggestedLocal areaFlexible hours3 days per week- ...appropriate activities in order to improve the regulatory environment through Agency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate. Mentoring newer staff members across the varied disciplines across multiple review...SuggestedWork at officeFlexible hours
$174.76k - $218.72k
...program and advisory board execution, and congress planning. Strong understanding of MLR/PRC processes, claims substantiation, and OPDP regulations. Demonstrated ability to thrive in a fast-paced biotech environment. Ability to travel 30%, including occasional weekends...SuggestedWork at officeLocal area- ...Legal, Medical, Compliance, Commercial teams, and external agencies to ensure SOP-compliant review processes. Coordinate support for OPDP submissions as required. Oversee promotional material lifecycle management, including approval tracking, re-approvals, expiration...SuggestedWork at officeImmediate start
$45 - $48 per hour
...Substantial understanding of relevant therapeutic area required. 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, ICH...SuggestedHourly payWork at officeLocal areaRemote workWorldwideVisa sponsorship$184.62k - $239.7k
...strategies and materials are scientifically accurate, appropriately substantiated, aligned with approved labeling, and compliant with FDA/OPDP, FTC, the PhRMA Code, internal policies, and other applicable requirements. This role also leads the development and continuous...SuggestedFixed term contractWork at officeFlexible hoursShift work3 days per week$169.68k - $254.52k
...quality materials. Manage post‑marketing promotional submissions and all communications with FDA’s Office of Prescription Drug Promotion (OPDP), including 2253 and time‑of‑first‑use submissions, and support pre‑clearance submissions as needed. Develop and execute forward‑...SuggestedWork at officeLocal area- ...date on latest industry events and trends related to key risk areas including OIG and FDA enforcement, CIA trends, and analysis of OPDP warning and untitled letters.Maintain current understanding of laws and regulations applicable to pharmaceutical/biotechnology companies...Suggested
$100 per hour
...pharmaceutical creative production, agency or in‑house, with direct exposure to MLR review workflows Demonstrated understanding of FDA OPDP guidance and 21 CFR 202, including fair balance, ISI placement, branded vs. unbranded vs. disease‑awareness content rules, and 2253...FreelanceWork at officeRemote workWork from homeFlexible hours- ...PM best practices, including methodologies, risk identification, and mitigation approaches Product launch, med/legal, and FDA 2253/OPDP submission experience Microsoft Office Suite: Word, Project, Excel, PowerPoint; Acrobat Professional; web-based routing and project...Work at officeLocal areaFlexible hours
- ...the ability to read and accurately interpret clinical trial data, publications, and prescribing information. Understanding of FDA/OPDP promotional regulations, fair balance requirements, and ISI standards. Range as a writer: able to move between rigorous scientific...Work at officeMonday to Friday
$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...Hourly payFull timeFreelanceRemote work$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...$214.1k - $264.5k
...direction and regulatory expertise for promotional materials, medical, and payer communications. 2. Serve as primary contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising...Full timeWork at officeLocal areaRemote workWork from home$109.9k - $179.3k
...promotion professionals at co‑promote partner companies Assist with interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, assist with helping to maintain working relationship and effective communication with FDA OPDP...Work at officeWorldwide- ...understanding of the advertising and promotion review and approval process. Strong experience in leading activities necessary for promotional OPDP submissions and new product labeling development. Demonstrated ability to manage multiple and diverse projects concurrently and meet...Work at office
- ...across media. You will partner with Commercial, Medical, Legal, and Regulatory teams to ensure scientific accuracy and adherence to FDA/OPDP, FTC, and PhRMA Code. The role requires 10+ years in pharma regulatory compliance focused on advertising and a strong background in...Fixed term contract
- ...approval, and maintenance for private label distribution products. You will ensure compliance with FDA, GMP, ISO standards and coordinate OPDP submissions when needed. Required is 1-2+ years in pharmaceutical labeling/artwork and a life sciences degree, with strong...Remote job
$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...Work at officeVisa sponsorship- ...functional governance, ensure scientific accuracy aligned with labeling, and drive submission processes including Form FDA 2253 and OPDP interactions. This role requires deep FDA promo knowledge and strategic leadership. You will partner with Commercial, Medical, Legal...
- ...Commercial teams to ensure FDA compliance and alignment with APPL guidance. The position requires deep knowledge of US FDA policies, OPDP guidance, and global regulatory practices, with 5+ years in regulatory affairs focused on advertising and promotion in biotech/...
- ...ensuring full FDA compliance and alignment with PhRMA guidelines and internal policies. You will lead Promotional Review Teams, manage OPDP submissions, monitor evolving regulations, mentor colleagues, and partner with Legal, Medical, Marketing and Global teams to enable...
- ...Marketing, Medical Affairs, and Legal to ensure campaigns meet regulatory requirements. The role focuses on US regulatory activities, interfacing with FDA OPDP, and guiding commercial teams while maintaining corporate integrity. #J-18808-Ljbffr Regeneron Pharmaceuticals, Inc