Job Description

Employment Type: Full time Work Schedule: Standard (Mon-Fri) Environmental Conditions: Office

Position Overview

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

Essential 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 clients.
• Provides project-specific local SIA services and coordination of these projects.
• May have contact with investigators for submission-related activities.
• Serves as the key contact at the 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 submission activities and mutually agreed-upon timelines.
• Ensures alignment of the submission process for sites and study with the critical path for site activation.
• Achieves PPD’s target cycle times for site activation.
• 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 budget(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 SIA activities onto PPD tracking databases accurately and in a 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 understands 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 processes.
• Negotiates within approved parameters both investigator grant budget negotiation parameters and contractual terms and conditions per company contractual considerations, client contractual considerations, and established processes with sites.
• Follows established escalation routes for negotiations.
• Ensures compliance with established negotiation parameters, contractual processes, and client expectations.
• Ensures compliance with budgetary guidance, templates, and processes.
• Identifies and assesses legal, financial, and operational risks and escalates them to the 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 start-up activities are aligned with contractual activities and mutually agreed-upon timelines.
• Achieves 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 pressure.