Country Approval Specialist (SSU)
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
- Prepares reviews and coordinates under guidance local regulatory submissions (MoH EC additional special national local applications if applicable e.g. gene therapy approvals viral safety dossiers import license) in alignment with global submission strategy.
- Provides under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local Startup services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates under guidance with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves companys target cycle times for site.
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities as required in accordance with agreed timelines.
- Enters and maintains trial status information relating to Startup activities onto company tracking databases in an accurate and timely manner.
- Ensures the local country study files and filing processes are prepared set up and maintained as per company WPDs or applicable client SOPs.
- Maintains knowledge of and understand company SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
Keys to Success:
Education
- Bachelors degree or equivalent and relevant formal academic / vocational qualification
Experience
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 2 years)
- In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role
Knowledge Skills Abilities
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently under direction as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
