Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

• Key responsibilities:

• Prepares, review and coordinates submissions (MoH, EC, applications if, e.g. gene therapy approvals, safety dossiers, import license) in alignment with global submission strategy.
• Provides strategy advice (MoH &/or EC) to clients.
• Develops and implements local submission strategy. Provides expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a timely manner.
• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as the need arises in Submission Team Meetings, Review Meetings and Project Team meetings.
• Coordinates 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 activations.
• Prepares 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.
• Develops country specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets(s) and payment schedules negotiations with sites.
• Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.
• Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
• Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
• Oversees country study files and ensures that they meet PPD WPD’s or client SOP’s.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Advises/mentos other SIA individuals assigned to support projects of responsibility, as appropriate
• Proactively identifies issues or anomalies in the regulatory process of a study, resolves or escalates as appropriate.

Keys to Success

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 5+ 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 digital literacy 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 direction, 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