Ctry Approval Spec

Work Schedule

Environmental Conditions

Job Description

Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.

Essential Functions and Other Job Information:

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 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 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 PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• 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.
• Entes and maintains trial status information relating to SIA activities onto PPD 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 PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in per company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes
Ensures compliance to established negotiation parameters, contractual process and client expectations
Ensures compliance of budgetary guidance, templates and process
Identifies and assesses legal, financial and operational risks and brings up to appropriate level of the organization per established processes
Provides recommendations and alternative resolutions to Investigator Contract negotiations through established escalation channels
Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed up timelines;
Achieve target cycle times for site activations

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).
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 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 regulations