Biotechnology Jobs

420 jobs for “Pharmaceutical Engineer-Ktp Associate-No”

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GSK · 10000+ people · Public

Principal Programmer Analyst

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  • Stevenage
  • Hybrid
  • Lead

Leads statistical programming for complex and pivotal clinical studies, developing, maintaining and validating analysis packages while ensuring compliance with Good Programming Practices and CDISC standards. Acts as a technical mentor to junior programmers and leads programming support for regulatory interactions with bodies such as the EMA and FDA, working in an agile, squad-based team alongside clinical, statistical and operational stakeholders.

R

Last month
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GSK · 10000+ people · Public

Director, Cardiovascular and metabolic diseases, Clinical Pharmacology Modeling and Simulation

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  • Baar Onyx
  • US$188,100 – US$313,500 pa
  • Director

Leads end-to-end Model-Informed Drug Development and clinical pharmacology strategy across the drug development lifecycle, from first-in-human studies through filing and lifecycle management. Sits in the Clinical Pharmacology and Quantitative Medicine organisation, partnering with digital medicine, translational imaging, modelling and biostatistics teams, and drafting regulatory content for FDA, EMA and ICH submissions.

MIDD · QSP · AI/ML

Last week
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GSK · 10000+ people · Public

SERM Medical Director

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  • London
  • Hybrid
  • Director

Provides medical and scientific leadership for pharmacovigilance and risk management of oncology assets in clinical development, interpreting safety data, detecting signals and delivering benefit-risk recommendations. Represents Safety on cross-functional matrix teams and governance committees, and interacts with regulators. Hybrid UK-based role with mentoring and process-improvement duties.

2 weeks ago
GSK logo

GSK · 10000+ people · Public

SERM Medical Director

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  • Belgium-Wavre
  • Hybrid
  • Director

Provides medical and scientific leadership for pharmacovigilance and risk management of oncology assets in clinical development, interpreting safety data, detecting signals and delivering benefit-risk recommendations. Represents Safety on cross-functional clinical matrix teams and governance committees, and may lead Safety Review Teams. Hybrid role based in the UK with global regulatory and partner interaction.

2 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.

AI

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
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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

Principal Programmer Analyst

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  • USA - Pennsylvania - Upper Providence
  • Hybrid
  • Lead

Lead programming activities for complex and pivotal clinical studies, developing, maintaining and validating analysis packages while ensuring compliance with Good Programming Practices and CDISC standards. Mentor junior programmers, support regulatory interactions with EMA and FDA, and bridge scientific requirements with technical solutions in an agile, squad-based global team.

R

Last month
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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.

AI

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)

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  • 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
GSK logo

GSK · 10000+ people · Public

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

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  • USA - Pennsylvania - Upper Providence
  • Hybrid · 2–3 days in office
  • US$221,925 – US$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 regulatory authorities on labelling standards and policy.

Yesterday

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