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    Health (Advertising)

 

  • General experience working in healthcare, life sciences and pharmaceutical advertising and promotional environments.

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  • Negotiation and drafting of agreements, contracts, documents and templates, such as for: ad content providers; ad development; ad exchanges; ad servers; ad publishers; data analytics providers; data licensing; data management; data management platform (DMP); data optimization; data privacy; data processing; data security; demand-side platform (DSP); digital advertising; insertion orders (IOs); master (MA); master services (MSA); media purchase; modifications of IAB terms and conditions; network services; supply-side platform (SSP); search engine optimization (SEO); targeting; third-party vendors.

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  • Negotiation, drafting and review of new and existing corporate policies relating to advertising and promotions.

 

  • Compliance with the Center for Biologics Evaluation and Research (CBER) procedures pursuant to various regulatory authorities such as the Public Health Service Act (42 U.S.C. ch. 6A § 201) and the Food Drug and Cosmetic Act (21 U.S.C. ch. 9 § 301).

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  • Compliance with the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use) processes, pursuant to 21 C.F.R. 314.81(b)(3)(i) and 21 C.F.R. 601.12(f)(4).

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  • Compliance with the Bar Code Label Requirement for Human Drug Products and Biological Products (69 Federal Register 9120, February 26, 2004) pursuant to 21 CFR 606.121(c)(13).

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  • Compliance with domestic and international guidelines and regulations from administrative agencies, governments and trade associations, such as the: Brazil Lei Geral de Protecao de Dados (LGPD); the California Confidentiality of Medical Information Act (CMIA); California Consumer Privacy Act (CCPA); California Privacy Rights Act (CPRA); California Department of Public Health; California Office of Attorney General; Canadian Anti-Spam Act (CAN-SPAM); ;Digital Advertising Alliance (DAA); European Union (EU) Charter of Fundamental Rights; EU General Data Protection Regulation (GDPR); EU Network Information Security (NIS) Directive; Federal Trade Commission (FTC); Health Insurance Portability and Accountability Act (HIPAA); Interactive Advertising Bureau (IAB); National Institute of Standards and Technology (NIST) Cybersecurity Framework NISTIR 8323; Network Advertising Initiative (NAI); New York State SHIELD Act; Telephone Consumer Protection Act (TCPA); United Kingdom (UK) Information Commissioner’s Office (ICO); Video Privacy Protection Act (VPPA).

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  • Compliance regarding prescription drug advertisements, regulated under the Food, Drug and Cosmetic Act (FD&C Act), 21 U.S.C. 301 et seq. Section 502(n), requiring that drug advertisements must include the legal name, the brand name (if one exists), the basic formula information showing each ingredient quantitatively, and summarizing side effects, contraindications and verifiable effectiveness.

 

  • Consultation regarding advertising and promotion materials, labeling and other brand-related activities.

 

  • Advertising and promotional review compliance for various adrenal, allergenic, analgesic, antibiotic, biologic, dermatological, narcotic, nasal, neuroscience, oncological, statin, surgical and ophthalmological products.

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  • FDA Office of Prescription Drug Promotion (OPDP) issues, such as; comments in response to ODPD communications, investigations, questions, and warning letters; compliance checklist and verification for ODPD audits and drug launch submissions and FDA-483 Inspection Observations; fair balance verification for drug risk information; research for advisory opinions; support for completing and submitting FDA Form 2253.

 

  • Consultation for a wide range of regulatory matters, such as advertising language, fraud and abuse, product promotional activities, product pricing, stark and anti-kickback issues.

 

  • Legal oversight and support during the upstream, midstream and downstream strategic planning stages of proposed advertising and promotional initiatives regarding broadcast media, editorial, marketing, online and visual materials reviewed by cross-functional domestic and international teams.

 

  • Consultation on copyright, patent and trademark issues related to proposed advertising and promotional initiatives.

 

  • Organization of promotional review committee (PRC) and medical, legal and regulatory (MLR) review committee secretarial functions, such as action items, agendas, committee notes, timelines and meeting logistics, to facilitate overall team workflow and deliverables.

 

  • Management of the legal review process for multiple brands and products simultaneously through all committee controls to final approval.

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  • Extensive training of all personnel engaging in any sales-related activities with medical and pharmacy personnel.

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  • Collaboration with editorial, production and regulatory personnel for the submission processes.

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  • Familiarity with the Biologics License Application (BLA) process pursuant to 21 CFR 600-680, and the Form 356h.

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  • Attended Medical, Legal and Regulatory (MLR) review committee meetings, took meeting notes during such discussion, then input all such information into the enterprise online content management system (CMS) for dissemination to the product team, for further review and comment.

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  • Consultation in civil litigations and class actions involving alleged violations of state or Federal advertising laws or Federal Trade Commission (FTC) rules, responses to cease and desist orders, injunctions by Federal courts and requirements for refunds or monetary damages to consumers for actual damages in civil lawsuits.

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  • Authored ad-tech marketing and sales standard form contract templates and a negotiation playbook with strategies and suggested language keyed to every template clause, and ad-tech-related corporate policies.

 

  • Close coordination with internal key personnel regarding brand marketing, compliance, and the preparations for global marketing operations, to identify and resolve legal issues and ensure that reviews are completed efficiently.

 

  • Utilization of proprietary internal reporting and systems tools to effectively communicate and actively manage the sequence of projects with the various domestic and international brand and project originators.

 

  • Facilitation of good practices (GxPs) and standard operating procedures (SOPs) through regulatory compliance spot audits, general adherence to the American Society of Quality (ASQ) Plan Do Check Act (PDCA) System and general guidance from the Medical Affairs Professional Society (MAPS).

 

  • Development and implementation of a risk aversion sales playbook, including particular guidance on verbal and written language formulations that may potentially imply fitness for a particular use, guarantees, performance expectations, representations, warrantees.

 

  • Extensive training of all personnel engaging in any sales-related activities with medical and pharmacy personnel.

 

  • Collaboration with editorial, production and regulatory personnel to facilitate execution of the submission processes. 

 

  • Collaboration with marketing groups, to review analytics, copy writing, editing and proofreading, as may be required. 

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  • Works directly with business clients, subject matter experts (SMEs), marketing and sales professionals, as well as offering guidance and practical solutions for improving the review process.

 

  • Interaction with external strategic planning and market research organizations, providing legal support for analytics and for identifying potential new markets.

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  • Collection and review of related privacy and data usage issues (such as the extent to and locations from which any PII is collected, distributed or used), corporate privacy audits, policies and protocols, EU and HIPAA considerations.

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  • Primary legal content reviewer and editor for assigned products, both branded and generic, reviewing advertising copy, incentives letters, labeling, marketing collateral, promotions, and sales training materials at all stages of the product development process.

 

  • Reviewed and edited all collateral materials (such as digital, print, sound and any other type of audible or visual media) for clarity of message, compliance with the American Medical Association (AMA) Manual of Style requirements, correct medical terminology references, grammatical and factual accuracy, presentation style (whether unembellished or over-inflated puffery), truthfulness, under expedited deadlines.

 

  • Responsible for confirming the accuracy of reference citations and verified that the most-current labeling and safety information instructions were clearly delineated. 

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  • Collaborated with the brand or generic teams and the marketing operations team to achieve the project milestones and to complete all final quality control (QC) checks, such as functional reviews of collateral media and promotional websites.

 

  • Reviewed final production proofs for all print and collateral materials.

 

  • Recommendation, research, sourcing, specification, procurement, testing and use of various content management system (CMS) platforms, such as: Altair; bit.ai; Bitrix24; box; Confluence; Conga Contracts; DialogsCMS; Drupal; eFileCabinet; Elise ECM; Evolphin Zoom; eZ Publish; Folloze; Hubb; InfiniteECM; IQVIA; Kissflow; Laserfiche; MarCom On Demand; Medidata; Ninox; Nintex Process Platform; Open Text; Pantheon; Pozative; ProcessWire; PublishNow; SepPortal; Squarespace; Veeva Vault; ViewCenter; Zoho docs; Zyyne.

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  • Recommendation, research, sourcing, specification, procurement, testing and use of various promotion management platforms for life sciences and pharmaceuticals, such as: actisCRM; bmp’online; CRM Pharma; CRMNEXT Pharmaceutical; FieldEZ; Infinitech; Inova; Kapture; Medismo; Pepper Flow; PharmaCode; Prophet CRM; SalesBabu; Stay In Front; Synergystix; Veeva CRM; Zinc.

 

    Last updated 210509_1332

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