Principal Ctry Approval Spec

4 weeks ago

Sydney, Australia Thermo Fisher Scientific Full time

Start Up Operations is a global department working to provide rapid site activation and patient access to our clients. Our innovative approach is designed to help save our clients time and money while driving industry-leading cycle times. Working in Start Up Operations, you are a very important step in our commitment to industry leadership and the relentless pursuit of excellence.

As a Principal Country Approval Specialist, you will manage the preparation, review and coordination of Country Submissions in line with global submission strategy.

Summarized Purpose:
Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

Essential Functions:

- Provides local regulatory strategy advice (MoH & EC) to internal clients.
- Provides project specific local submission strategy, technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
- 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.
- Works with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- 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 start up 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 start up individuals assigned to support projects of responsibility, as appropriate.
- Prepares and maintains country master document templates and other PPD regulatory intelligence systems, as may be required and assigned

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 8+ 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:
Knowledge, Skills and Abilities:

- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Solid 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 mínimal supervision, as required
- Ability to mentor fellow team members in a positive and effective manner
- Excellent team player with teambuilding skills
- Good organizational and planning skills
- Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations

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