Clinical Submission Specialist

il y a 3 semaines

IssylesMoulineaux, France Johnson & Johnson Temps plein

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we, in Italy, are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

**Janssen France is recruiting a Clinical Submission Specialist (M/F) on a permanent contract.**

**Role based in Issy-les-Moulineaux. 3 days of home office per week.**

**Position summary**:
Performs clinical trial submissions to Ethical Committees and Health Authorities (in countries with no or limited GRA support) within the respective country, according to GCO SOPs, policies and local regulatory requirements.

May contribute to process improvement, training and mentoring of other submission specialists.

The Submission Specialist reports into the Quality & Compliance_Submission Team Manager.

**Principal responsibilities**:

- Ensures timely and formally complete submission to Ethics Committees (ECs) in respective country and if applicable to federal Health Authorities (HAs) of initial submission packages and substantial amendments in adherence to internal SOPs, policies and local regulatory requirements. Closely collaborates on all submissions with the respective study teams consisting out but not limited to Clinical Trial Manager (CTM), Local Trial Manager (LTM), Site Manager (SM) and Clinical Trial Assistant (CTA).
- Develops draft version of local documents (such as ICFs, French Protocol Summary, Patient Card ) to provide to LTM.
- Compiles in liaison with the study teams (CTM, LTM, SM and CTA) complete and accurate regulatory documents for submission to ECs & HAs. Is responsible for the formal completeness of the submission packages and closely collaborates with the study teams on the accurate content.
- Follows up closely and alerts on all response timelines for requests/questions received from agencies in close collaboration with the study team for initial and consecutive submissions.
- Constantly looking for ways to improve existing processes in order to decrease the time to EC& HA approval.
- Is fully aware and ensures to be trained on the latest SOPs, as well as legal and local regulatory requirements for EC and HA submission in close collaboration with the Quality and Compliance Manager/Specialist.
- Ensures the respective information on submissions (e.g. submission and approval data) is updated promptly and provided to the relevant study teams.
- Takes ownership of country specific submission guidelines if applicable and ensures submission guidelines are kept up to date.
- Ensures the submission documents are named correctly for central filing in the electronic Trial Master File (vTMF) by the CTA.
- Compiles and provides submission packages to study teams for filing in Trial Center Files (TCFs)
- Supports obtaining IMP Import licenses, where applicable / Sends Safety reports to Local EC (DSURs) as per Local Regulation (Study under EUCTD).
- Completes and updates dedicated local trackers to support the tracking and the analyze of metrics about EC submissions /MESRI submissions (Health Ministry for Biological collection export authorization) /HA submissions (GMO dossier - IMP Import license certificate).

**Qualifications**:
**Education & experience**:

- A minimum of a BA/BS degree is preferred. Recognized occupation formal training in related profession and/or robust experience in the job may compensate academic education. Robust knowledge on existing local regulations and agile to be up to date on legal updates.
- Skills set corresponding with 2+ years relevant clinical trial experience.
- Proficient in French and in English. Able to communicate effectively with internal as well as external stakeholders.
- Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint),
- Strong interpersonal and negotiating skills.
- Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment.
- Able to perform activities in a timely and accurate manner and work independently within area of responsibility.
- Able to accept high flexibility and to set and accept changing priorities.
- Agility and professional in managing databases and electronic systems.

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