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Regulatory Compliance Officer Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

Yoh has a long term contract opportunity for a REGULATORY COMPLIANCE OFFICER to join our client, the world leader in the consumer goods industry, located in Cambridge, MA.

JOB RESPONSIBILITIES:

- Contribute to the development, production and maintenance of the appropriate tracking and compliance tools, reports, plans, tasks and activities pertaining to the management of the GPE compliance management system.
- Perform investigation of deviations and monitoring of corrective actions and preventive actions (CAPA) relating to noncompliance issues and findings and propose appropriate long-term strategies to line management.
- Perform compliance analysis and contribute to development, production and maintenance of adequate reporting methods to the hierarchy to detect and monitor any significant compliance deviations to the company quality standards and/or regulatory requirements Track and communicate on compliance.
- Ensure tasks and activities are performed according to the work instructions, procedures and Policies in place.
- Contributes as an author or a reviewer to GPE Quality Documents developed within the Company and relating to compliance monitoring.
- Interface with internal and external stakeholders and ensure that the appropriate contact points are established with the other groups (within Quality, Training & Compliance or outside) to respond and address gaps or compliance issues that need resolution by team specialists.
- Support Affiliates on compliance matters as required.
- Support the conduct of PV audits/regulatory inspections.
- Participate to the Development of compliance programs and quality tools to enhance GPE global quality and adherence to SOPS and Regulations.

JOB QUALIFICATIONS:

- Scientific background: Usually Baccalaureate plus five (5) years (Pharm D., Health/Lifescience) with at least two (2) years of experience in Pharmacovigilance/Pharmaceutical environment and safety in an international environment.
- Additional degree in pharmaceutical regulatory environment, or in business management or in quality management would be much appreciated.
- In depth understanding of international Pharmacovigilance requirements/updates in particular EU/FDA requirements/international guidelines, (eg ICH/CIOMS, Clinical development methodology and knowledge of Clinical Trial guidelines (GCP) and regulation).
- Good understanding of Corporate Pharmacovigilance Duties and Rules in a Pharmaceutical Company.

DISCOVER ALL THAT'S POSSIBLE WITH YOH. APPLY NOW.

RECRUITER: Natane Peslis

Yoh is a professional staffing provider with over 70 years of experience in the short- and long-term staffing services industry.

Yoh, a Day and Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: CLINICAL

MONJOBJ2WNECLIN

Ref:

SFSF: REN

Projektdetails

  • Einsatzort:

    Cambridge, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh