Biotechnology Jobs

500 jobs for “Clinical Supply Irt Specialist”

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GSK · 10000+ people · Public

Medical Director-Oncology Clinical Development - GI

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  • London
  • Hybrid · 2–3 days in office
  • US$222,750 – US$371,250 pa
  • Director

Serves as the physician within a clinical programme team, leading medical monitoring and safety oversight for oncology studies and interpreting clinical and safety data. Partners with the Senior Scientist and cross-functional teams on protocol development, regulatory interactions and investigator engagement, with a focus on GI oncology. Requires an on-site office presence two to three days a week.

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3 weeks ago
GSK logo

GSK · 10000+ people · Public

Medical Director-Oncology Clinical Development - GI

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  • Waltham, United States
  • Hybrid · 2–3 days in office
  • US$222,750 – US$371,250 pa
  • Director

Serves as the physician on a clinical programme team, leading medical monitoring and safety oversight for GI oncology studies. Interprets clinical and safety data, contributes to protocol development, and engages investigators and regulators. Works within a Clinical Matrix Team alongside Clinical Operations, Biostatistics, Regulatory and Pharmacovigilance, with on-site presence 2-3 days a week.

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3 weeks ago
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GSK · 10000+ people · Public

Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)

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  • London
  • Hybrid · 2–3 days in office
  • Director

Develops and executes global and regional regulatory strategies for assigned assets in the Respiratory, Immunology & Inflammation therapeutic group, managing regulatory interactions, submissions and review processes across regions. Ensures compliance with internal GSK processes and regulatory requirements to secure optimal labelling, working closely with global counterparts and commercial teams.

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2 days ago
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GSK · 10000+ people · Public

Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology

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  • London
  • Hybrid · 2–3 days in office
  • Director · manages people

Leads a global oncology labelling team, managing the labelling process from early development through lifecycle management and ensuring regulatory compliance. Serves on the Global Labelling Committee, advises senior R&D, Safety, Regulatory and Commercial leaders, and engages with regulatory authorities on labelling standards and policy.

Yesterday
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GSK · 10000+ people · Public

Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology

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  • Siena, Italy
  • Hybrid · 2–3 days in office
  • €123,000 – €205,000 pa
  • Director · manages people

Leads a global oncology labelling team, managing the labelling process from early development through lifecycle management and ensuring regulatory compliance. Serves on the Global Labelling Committee, advises senior R&D, Safety, Regulatory and Commercial leaders, and engages with regulatory authorities on labelling standards and policy.

Yesterday
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GSK · 10000+ people · Public

Principal Medical Writer

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  • Durham, United States
  • Lead

Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents and submission dossiers. Manages end-to-end writing projects, coordinating contributors, timelines and quality checks, and acts as subject matter expert on medical writing standards, CTD structure and regulatory expectations while driving process improvement and audit readiness.

3 months ago
GSK logo

GSK · 10000+ people · Public

Principal Medical Writer

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  • London
  • Lead

Lead authoring and strategic planning of clinical and regulatory documents such as protocols, clinical study reports, briefing documents and CTD submission dossiers. Manage end-to-end writing projects, coordinating contributors, timelines and quality checks, and act as subject matter expert on medical writing standards and regulatory expectations while driving process improvement and audit readiness.

3 months ago
GSK logo

GSK · 10000+ people · Public

Director, Global Real-World Evidence & Health Outcomes Scientist, Oncology

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  • Waltham, United States
  • Hybrid
  • US$204,000 – US$340,000 pa
  • Director

Leads the design and execution of real-world evidence and health outcomes studies for oncology assets, managing timelines, budgets and quality of protocols, analyses and publications. Advises internal medical, market access and commercial teams and external experts on evidence strategy for HTA submissions, reimbursement and value-based pricing. Requires close collaboration across a matrix and deep knowledge of real-world data sources and payer needs.

3 weeks ago
GSK logo

GSK · 10000+ people · Public

Director, Global Real-World Evidence & Health Outcomes Scientist, Oncology

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  • London
  • Hybrid
  • US$204,000 – US$340,000 pa
  • Director

Leads the design and execution of real-world evidence and health outcomes studies across oncology assets, managing timelines, budgets and quality of protocols, analyses and publications. Advises internal medical, market access and commercial teams and external experts on evidence strategy for HTA submissions, reimbursement and value-based pricing, while building knowledge of real-world data sources and payer needs.

3 weeks ago
GSK logo

GSK · 10000+ people · Public

Director, Global Real-World Evidence & Health Outcomes Scientist, Oncology

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  • Rockville Tower Oaks Blvd
  • Hybrid
  • US$204,000 – US$340,000 pa
  • Director

Leads the design and delivery of real-world evidence and health outcomes studies across oncology assets, managing protocols, budgets, timelines and vendor deliverables. Partners with medical, market access, R&D and commercial teams plus external experts to shape evidence for HTA submissions, reimbursement and value-based pricing. Requires deep knowledge of RWD sources and payer evidence requirements.

3 weeks ago
GSK logo

GSK · 10000+ people · Public

Director, Global Real-World Evidence & Health Outcomes Scientist, Oncology

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  • Durham Blackwell Street
  • Hybrid
  • US$204,000 – US$340,000 pa
  • Director

Leads the design and delivery of real-world evidence and health outcomes studies for oncology assets, managing protocols, budgets, vendors and reporting from concept to publication. Advises medical, market access and commercial teams on payer and HTA evidence needs, and builds relationships with external experts and data partners.

3 weeks ago
GSK logo

GSK · 10000+ people · Public

Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology

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  • Rockville, United States
  • Hybrid · 2–3 days in office
  • £221,925 – £369,875 pa
  • Director · manages people

Leads a global oncology labelling team, managing the labelling process from early development through lifecycle management and ensuring regulatory compliance. Serves on the Global Labelling Committee, advises senior R&D, Safety, Regulatory and Commercial leaders, and engages with regulatory authorities on labelling standards and policy.

3 months ago
GSK logo

GSK · 10000+ people · Public

Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)

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  • Belgium-Wavre
  • Hybrid · 2–3 days in office
  • €89,250 – €231,000 pa
  • Director

Develops and executes global and regional regulatory strategies for assigned assets in respiratory, immunology and inflammation, managing regulatory interactions, submissions and review processes across major markets. Ensures compliance with internal policies and regulatory requirements to deliver optimal labelling, working closely with global, regional and commercial teams. Hybrid role with mandatory on-site collaboration two to three days per week.

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2 days ago
GSK logo

GSK · 10000+ people · Public

Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)

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  • Rockville Tower Oaks Blvd
  • Hybrid · 2–3 days in office
  • US$138,600 – US$231,000 pa
  • Director

Develops and executes global and regional regulatory strategies for assigned assets in the Respiratory, Immunology & Inflammation therapeutic group, managing regulatory interactions, submissions and review processes across regions. Ensures compliance with internal GSK processes and regulatory requirements to deliver optimal labelling, working closely with global counterparts and commercial teams.

AI

2 days ago
GSK logo

GSK · 10000+ people · Public

Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)

Save job
  • Durham Blackwell Street
  • Hybrid · 2–3 days in office
  • US$138,600 – US$231,000 pa
  • Director

Develops and executes global and regional regulatory strategies for assigned assets in respiratory, immunology and inflammation, managing regulatory interactions, submissions and review processes across major markets. Ensures compliance with internal GSK processes and regulatory requirements to deliver optimal labelling, working in a matrixed team and liaising with commercial and global counterparts.

AI

2 days ago

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