Work Schedule

Environmental Conditions

Job Description

Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation
The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
 

Sr. Ctry Approval Spec (CAS-RA)

What You'll Do:
• Prepare, review and coordinate 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.
• Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Ensure guidelines and processes are followed for effective internal team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Act as a key-contact at country level for all submission-related activities.
• Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation.
• Achieve company’s target cycle times for site activations.
• Prepare the regulatory compliance review packages, as applicable.
• Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
• Develop country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
• Support the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s.
• Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate
• Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate.

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
• Good judgment and decision-making skills
• Basic medical/therapeutic area and medical terminology knowledge
• Ability to work in a team environment or independently, with minimal supervision, as required
• Ability to mentor fellow SIA team members in a positive and effective manner
• Excellent team player with teambuilding skills
• Basic organizational and planning skills
• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations