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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory submissions and clinical trial documentation, with strong organizational and communication skills to effectively collaborate with stakeholders and manage study start-up processes.
Highest-signal resume keywords
Regulatory SubmissionsClinical Trial ApplicationsStudy Documentation DevelopmentAttention To DetailCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsClinical ResearchProtocol DevelopmentInformed Consent FormsInvestigator Brochures
Soft Skills
Organizational SkillsCommunication SkillsInterpersonal SkillsIndependent WorkTime Management
Industry Keywords
Life SciencesStudy Start-UpEthics Committee SubmissionsStakeholder CoordinationRegulatory Approvals
About the role
Key responsibilities & impact- Deliver site start-up and activation work to a high standard
- Assist in preparing and submitting regulatory documents, including clinical trial applications and ethics committee submissions
- Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
- Maintain accurate and up-to-date records of regulatory submissions and approvals
- Support study teams in developing study documents, including protocols, informed consent forms, and investigator brochures
- Participate in study start-up meetings and provide input on regulatory requirements and timelines
Requirements
What you’ll need- Bachelor's degree in life sciences or a related field
- Previous experience in clinical research or regulatory affairs preferred, but not required
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment
- Willingness to travel as required (approximately 5%)
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways