Senior Clinical Development Scientist,IGT

Philips
Shanghai
Workplace: OnsiteFull timeFunction: Research & Scientific (R&D)Experience: 3+ yearsEducation: mastersSkills: ["Data analysis","Interpretation","Continuous improvement","Strategic planning","Medical writing"]

Analyze clinical trial protocols and studies to ensure regulatory compliance and alignment with strategic objectives. Author compliant clinical evaluation and study reports for regulatory submissions, troubleshoot clinical data issues, and synthesize findings for dissemination (e.g., abstracts and publications). Develop clinical development and market access strategies, perform literature reviews for NPI and LCM evidence generation, support KOL and investigator relationships, and present results to internal stakeholders.

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FursaFursa
Philips
Philips
2 months ago

Senior Clinical Development Scientist,IGT

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Last checked: 27 days agoStatus: Live

Job Summary

Analyze clinical trial protocols and studies to ensure regulatory compliance and alignment with strategic objectives. Author compliant clinical evaluation and study reports for regulatory submissions, troubleshoot clinical data issues, and synthesize findings for dissemination (e.g., abstracts and publications). Develop clinical development and market access strategies, perform literature reviews for NPI and LCM evidence generation, support KOL and investigator relationships, and present results to internal stakeholders.
Location: Shanghai
Workplace: Onsite
Employment Type: Full time
Job Function: Research & Scientific (R&D)
Seniority: Mid level

Key Responsibilities

  • •Analyze clinical trial protocols and studies to ensure adherence to regulatory requirements and strategic objectives, recommending protocol optimizations.
  • •Develop and write Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and clinical sections of regulatory submissions according to procedures, templates, and standards.
  • •Troubleshoot complex clinical data collection, analysis, and reporting issues to maintain data integrity, accuracy, and consistency.
  • •Critically analyze clinical study data and synthesize findings to support dissemination efforts such as abstracts, white papers, and peer-reviewed publications.
  • •Develop clinical development and market access strategies, conduct literature searches and reviews to support evidence generation for NPI and LCM, and support KOL and investigator relationships.

Key Requirements

  • •Master's Degree in Clinical Medicine.
  • •MD preferred, with 3 years of clinical experience in equipment/device or R&D.
  • •Ability to analyze clinical trial protocols and studies while ensuring regulatory compliance and protocol optimization recommendations.
  • •Ability to craft compliant Clinical Evaluation Reports (CERs) and Clinical Study Reports (CSRs) and clinical sections of regulatory submissions.
  • •Knowledge of medical terminology and regulatory requirements, with strong report writing and clinical evidence generation capabilities.
Experience:3+ yearsClinical trialsRegulatory submissionsMedical devices
Education:Master's
Skills:Data analysisInterpretationContinuous improvementStrategic planningMedical writing

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn