Sr Ctry Approval Spec [UT-865]

Sr Ctry Approval Spec [UT-865]

12 abr
Departamento de Maipú

12 abr


Departamento de Maipú

Summarized Purpose:

As a Sr Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.

Essential Functions:

- Prepares, review and coordinates 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 local regulatory strategy advice (MoH &/or EC) to internal clients.

- Develops and implements local submission strategy.

- Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.

- Provide project specific local Site Intelligence and Activation (SIA) services and coordination of these projects

- Serves 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.

- 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 required 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 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.

- Directs/mentors 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.

Job Qualification

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).

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 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

Working Environment:

PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner

Able to work upright and stationary and/or standing for typical working hours

Able to lift and move objects up to 25 pounds

Able to work in non-traditional work environments

Able to use and learn standard office equipment and technology with proficiency

May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments

Able to perform successfully under pressure while prioritizing

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