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Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. Provide dedicated support for executive and senior management employment matters, including offer arrangements, employment agreements, separations, restrictive covenants, compensation-related employment issues, and incentive-related questions, in coordination with relevant subject matter experts.

BioNTech SE

Senior Director, US Employment Law

Kiniksa is seeking an accomplished and strategic Senior Director, Clinical Translational Scientist reporting to GVP, Research & Non-Clinical Development to play a critical leadership role in advancing clinical-stage development programs from early clinical development through proof-of-concept and registrational studies. This individual will serve as a key scientific leader across multidisciplinary teams, integrating insights from Research, Clinical Development, Clinical Pharmacology, Bioanalysis, Biostatistics, Regulatory Affairs, and Medical Affairs to maximize the probability of technical and regulatory success across the portfolio.

Kiniksa Pharmaceutical

Senior Director, Clinical Translational Scientist

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The successful candidate must have strong written and oral communication skills and have experience writing regulatory briefing documents, leading meetings with health authorities, and partnering with regulatory agencies to advance complex therapies (experience with cell or gene therapies is preferred.) An additional key responsibility will be working to develop and execute the regulatory roadmap to support future European Union submissions for existing products, including regulatory gap assessments, EU engagement strategy, pediatric planning, and preparation for Marketing Authorization Applications (MAAs).

YEAR

bluebird bio, Inc.

Sr. Director, Regulatory Strategy

The Director establishes and maintains systems to control the collection, maintenance, retrieval and retention of clinical information and participate on committees and task forces which have medical records or clinical information management objectives. Encompass Health is a trusted leader in post-acute care with over 150 nationwide locations and a team of 36,000 exceptional individuals and growing!

Encompass Health Corp

Health Info Mgmt Svc Director

HOUR

The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling and is: Responsible, with minimal supervision for providing regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, Commercial, to ensure successful development and maintenance of labeling managed within PDT BU’s Global Labeling function, pertaining to pharmaceutical drug and device. Dimensions and Aspect: In close collaboration with the Client R&D labeling function, oversees the direction, management and implementation of the labeling processes, templates, tools and systems to improve efficiency, productivity and quality and consistency across products and compliance with regulatory labeling guidance.

US Tech Solutions, Inc.

Associate Director, Global RA Labeling Lead # 26-22779

jobdiva

Director, Integrated Performance Insights & Forecasting will lead performance analytics, forecasting, and integrated insights for rare disease brands by leveraging specialty pharmacy, claims, EMR, CRM, and other data sources to understand market dynamics, therapy adoption, and brand performance. Integrated Insights & Customer Analytics Lead brand reporting and hands-on analytics by translating large and complex datasets into actionable, integrated insights, using specialty pharmacy data, claims, EMR, CRM, and third-party sources.

ITF Therapeutics

Sr. Director, Integrated Performance Insights & Forecasting

Provide clear, actionable guidance on complex topics, including: Engagements with Healthcare Professionals (HCPs), sponsorships, grants, and charitable contributions, patient support programs, patient advocacy group interactions, market access and emerging commercialization models. We are seeking a strategic, enterprise-minded Senior Director, Healthcare Compliance reporting to VP, Head of Compliance to serve as the primary Compliance & Ethics business partner to our Commercial organization and key external-facing functions (Medical Affairs, Patient Services, and Patient Advocacy).

Operations Consultant Jobs in Louisville, KY

Senior Director, US Employment Law BioNTech SE

Senior Director, Clinical Translational Scientist Kiniksa Pharmaceutical

Sr. Director, Regulatory Strategy bluebird bio, Inc.

Health Info Mgmt Svc Director Encompass Health Corp

Associate Director, Global RA Labeling Lead # 26-22779 US Tech Solutions, Inc.

Sr. Director, Integrated Performance Insights & Forecasting ITF Therapeutics

Senior Director, Healthcare Compliance Kiniksa Pharmaceutical

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