Country Approval Specialist
Year Mumbai, Maharashtra, India
Job Description
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Job Scope :
Participates in the management and preparation, review and coordination of Country
Submissions in line with global submission strategy.
Functions and Responsibilities:
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
- Provides project specific local SIA 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
timelines; ensures alignment of submission process for sites and study are aligned to the
critical path for site activation.
- Achieves PPD\xe2\x80\x99s target cycle times for site.
- May work with the start-up CRA(s) to prepare the regulatory compliance review
- May develop country specific Patient Information Sheet/Informed Consent form
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities, as required, in accordance with agreed
- Entes and maintains trial status information relating to SIA activities onto PPD tracking
- Ensures the local country study files and filing processes are prepared, set up and
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current
Qualifications:
Education and Experience:
Bachelor\'s degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job
(comparable to 2+ years).
Knowledge, Skills and 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
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Job Detail
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Job IdJD3054116
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear