Sr. Ctry Approval Spec (CAS-EC)

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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-EC)

• 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