Senior PRO/COA Strategy Consultant

Job not on LinkedIn

🔥 1 minute ago

🐊 Florida, New York, +1 more states – Remote

🐊 Florida – Remote 🗽 New York – Remote 🤠 Texas – Remote

⏳ Contract/Temporary

🟠 Senior

🧐 Strategy

🦅 H1B Visa Sponsor

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👻 Ghost score 11%

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TransPerfect

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

💼 Consulting

⚖️ Legal

📣 Marketing

Consulting • Legal • Marketing

TransPerfect is a global language and technology company that provides translation, localization, interpretation, and content services combined with software and AI-powered tools such as the GlobalLink translation management platform. It offers multilingual marketing, legal and life‑sciences regulatory support, contact center/BPO services, multimedia localization, and solutions for website, software and app globalization. TransPerfect serves large enterprise and Fortune 500 clients across dozens of industries and supports content in 200+ languages.

📋 Description

• Develop and maintain PRO/COA components of asset evidence strategies with asset leads • Conduct disease, patient-experience, competitive, regulatory, and endpoint landscape reviews • Lead fit-for-purpose PRO/COA evidence-generation studies from concept through completion • Design studies, develop protocols, oversee vendors, interpret findings scientifically, and disseminate results • Develop or refine conceptual models and identify and prioritize concepts of interest • Assess PRO/COA instruments for fitness for purpose and identify evidence gaps • Support endpoint strategy development and COA evidence-generation planning • Review and provide input on protocols, endpoint sections, statistical analysis plans, and related study documents • Prepare recommendations, decision-support materials, and documentation for cross-functional review • Participate as the PRO/COA subject matter expert in internal and partner-facing working sessions • Support vendor engagement and oversight for discrete COA evidence-generation activities as needed • Work in a strategic and scientific capacity rather than primarily performing administrative or project-management duties

🎯 Requirements

• Advanced degree in a relevant field such as outcomes research, psychometrics, epidemiology, psychology, public health, or a related discipline • Approximately 8 or more years of relevant PRO/COA experience in pharmaceutical, biotechnology, consulting, or regulatory settings • Demonstrated experience developing PRO/COA strategies for clinical development programs, preferably including early development • Strong knowledge of patient-focused drug development, instrument selection, content validity, psychometric evidence, meaningful-change interpretation, and endpoint positioning • Experience reviewing clinical protocols, statistical analysis plans, and regulatory or evidence-planning documents • Ability to synthesize complex evidence and communicate clear recommendations to cross-functional stakeholders • Demonstrated ability to work independently, manage competing priorities, and operate effectively in a matrixed and co-development environment • Experience in immunology, dermatology, gastroenterology, or neurology is desirable but not required • Confidentiality and contracting requirements must be completed before receiving program-specific confidential information

🏖️ Benefits

• No benefits specified in the posting