Senior Submissions Specialist - Paris, France

Company
PPD
Location
Ivry, France
Salary
Competitive
Posted
19 Sep 2019
Closes
19 Oct 2019
Ref
1160927
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Senior Submissions Specialist - Office based, Ivry Sur-Seine

Due to a period of sustained growth PPD is currently looking to hire a number of Study Start-Up/Submission specialists to join our office based team in Paris, France.

PPD is a leading global CRO with more than 21,000 employees worldwide. We offer integrated drug development, laboratory and life cycle management services to our clients across the pharmaceutical, biotech and medical devices industries globally.

Known internally as Country Approval Specialists, the purpose of the CAS role is to manage the preparation, review and coordination of country submissions in line with global submission strategy.

Responsibilities include:


    Prepare, review and coordinate, under guidance, 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, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients,

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

    May have contact with investigators for submission related activities

    Key-contact at country level for either Ethical or Regulatory submission-related activities

    Coordinates, under guidance, 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

    May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable

    May develop country specific Patient Information Sheet/Informed Consent form documents

    May assist with grant budgets(s) and payment schedules negotiations with sites.

    Support the coordination of feasibility activities, as required, in accordance with agreed timelines

    Enter and maintain trial status information relating to Site Intelligence and Activation (SIA) activities onto PPD tracking databases in an accurate and timely manner

    Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs


Qualifications:

Education and Experience:


    Bachelor's degree

    2 years of submissions/study start up experience or equivalent combination of education, training, and experience.


Knowledge, Skills and Abilities:


    Strong attention to detail and quality of documentation

    Good negotiation skills

    Good computer skills and the ability to learn appropriate software

    Fluent in French and English

    Basic medical/therapeutic area and medical terminology knowledge

    Ability to work in a team environment or independently, under direction, as required

    Basic organizational and planning skills

    Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations


If you feel you have the necessary skills and experience for the role then please apply now, alternatively, contact Adam Davis, Senior Recruiter for more information - adam.davis@ppdi.com

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PPD is an equal opportunity employer (EOE) that will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, and veteran or disability status by embracing diversity and the responsibilities of corporate citizenship in our communities. PPD values our former military and transitioning service member's service.

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