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Technical Project Manager – GxP, Clinical Development
D-ploy GmbH. Coordinate the delivery of technical projects and initiatives within a regulated pharmaceutical environment .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing technical projects within regulated pharmaceutical environments, focusing on GxP-validated systems and effective coordination with cross-functional teams and external vendors. Strong project planning, risk management, and communication skills are essential for successful project delivery.
Highest-signal resume keywords
Technical Project ManagementGxP-Validated SystemsSaaS Solutions CoordinationProject Planning and CoordinationRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project PlanningRisk ManagementIssue TrackingDocumentation ManagementTimeline ManagementDeliverable ManagementDependency ManagementGxP ComplianceComputerized System ValidationClinical Development
Soft Skills
Organizational SkillsProblem-Solving SkillsCommunication SkillsCross-Functional CollaborationIndependence
Tools & Technologies
SaaS SolutionsProject Management ToolsCollaboration PlatformsDocumentation ToolsVendor Management Systems
Certifications & Qualifications
Valid Criminal Record Extract
Industry Keywords
PharmaceuticalBiotechnologyLife SciencesRegulated EnvironmentClinical DevelopmentMedical WritingRegulatory SubmissionsGlobal Pharmaceutical TeamsGeographically Distributed Stakeholders
About the role
Key responsibilities & impact- Coordinate the delivery of technical projects and initiatives within a regulated pharmaceutical environment
- Develop and maintain project plans, including timelines, milestones and key deliverables
- Coordinate with business stakeholders, technical teams and external vendors to support project delivery
- Organize and facilitate project meetings, capture action items and follow up on outstanding activities
- Identify, track and manage project risks, issues and blockers, ensuring appropriate follow-up and escalation
- Manage external technology vendors involved in SaaS solutions and systems
- Support the delivery of projects involving GxP-validated and qualified systems, ensuring alignment with applicable regulatory and quality requirements
- Maintain project documentation and communicate progress, risks and key updates to relevant stakeholders
Requirements
What you’ll need- Proven experience as a Technical Project Manager, IT Project Manager, Delivery Owner or in a similar role, preferably within the pharmaceutical, biotechnology or life sciences industry
- Demonstrated experience delivering projects involving GxP-validated and qualified systems
- Experience managing technical projects in regulated environments, ideally within clinical development, medical writing or regulatory submissions
- Strong project planning and coordination skills, including managing timelines, deliverables, risks, issues and dependencies
- Experience coordinating SaaS solutions and managing external technology vendors
- Ability to work effectively with cross-functional teams, business stakeholders and technical specialists
- Strong organizational, problem-solving, documentation and communication skills
- Ability to work independently and effectively in an international environment
- Fluency in English
- Valid criminal record extract, not older than three months, required
- Nice to have: Experience working with global pharmaceutical teams and geographically distributed stakeholders
- Nice to have: Familiarity with computerized system validation (CSV) processes in GxP-regulated environments
Benefits
Comp & perks- Broad range of tasks and responsibilities
- Friendly and international working environment
- Professional development opportunities
- Referral program (“Fishing for Friends”)
- Company-sponsored events