Compliance Scientist in Regulatory Affairs
On behalf of our client, an international biopharmaceutical company, Swisslinx is looking for a Compliance Scientist. In this role you will manage regulatory document lifecycles, oversee training and compliance activities, support audits and inspections, and perform various administrative and project-related tasks to ensure departmental effectiveness and regulatory adherence!
Contract type - 6 months
Start Date - ASAP
Location - Bern
Workload - 100%
YOUR MISSION:
Procedural documents management
- Support procedural document preparation/review and lifecycle management
- Ensure compliance of GRA with local and global procedural documents
- Maintenance of the company online glossary with GRA definitions
Training
- Training analysis and assignment
- Maintenance of training presentations
- Onboarding newcomers to the department
- Facilitate classroom training sessions
- Support annual reviews of training curricula
Compliance activities
- Support regulatory agency inspections and audits including pre-inspection and related follow-up activities as needed
- Audit readiness activities including managing eStaff Record filing repository
- Support tracking of audits & inspections performed in GRA
- Support management of quality non-compliance events in GRA, such as deviations and CAPAs
Reporting and Analytics
- Preparation and/or review of various compliance reports
- Prospective monitoring of various compliance indicators
Other
- Management of the group inbox
- Project support activities as required
- Administrative activities such as scheduling meetings and meeting minutes
- Updates to SharePoint sites
- Meeting attendance
- Preparation, Review and Distribution of compliance Newsletter
General
- Applies practical knowledge of job area typically obtained through advanced education and work experience
- Works independently with general supervision to achieve operational targets with direct impact on departmental results
- Problems faced are difficult but typically not complex, sometimes requiring understanding of broader set of issues
- May influence others within the job area through explanation of facts, policies, and practices
- Select jobs may have formal supervisory responsibilities for support employees
YOUR BACKGROUND:
â?¢ Excellent knowledge of English (MANDATORY) and German (ADVANTAGEOUS).
â?¢ Bachelor degree in a Life Science or Business, Advanced degree in a Life Science (PhD,MD) or Business (MBA) an advantage.
â?¢ 1+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred.
â?¢ Thinks beyond and maintains an external and strategic focus
â?¢ Builds bridges and helps teams develop collaboration
â?¢ Unleashes outcomes and creates an accountable work environment
â?¢ Ignites agility and instills personal flexibility in self and teams
â?¢ Inspires the future and ensures clarity around the strategy
â?¢ Cultivates talent and hires/coaches effectively
WHAT'S ON OFFER
â?¢ An initially 6 month contract at an internationally-renowned biopharma company.
â?¢ A varied job in a dynamic but stable environment with the opportunity for professional development.
â?¢ A competitive salary.
If this sounds like you, donâ??t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
Contract type - 6 months
Start Date - ASAP
Location - Bern
Workload - 100%
YOUR MISSION:
Procedural documents management
- Support procedural document preparation/review and lifecycle management
- Ensure compliance of GRA with local and global procedural documents
- Maintenance of the company online glossary with GRA definitions
Training
- Training analysis and assignment
- Maintenance of training presentations
- Onboarding newcomers to the department
- Facilitate classroom training sessions
- Support annual reviews of training curricula
Compliance activities
- Support regulatory agency inspections and audits including pre-inspection and related follow-up activities as needed
- Audit readiness activities including managing eStaff Record filing repository
- Support tracking of audits & inspections performed in GRA
- Support management of quality non-compliance events in GRA, such as deviations and CAPAs
Reporting and Analytics
- Preparation and/or review of various compliance reports
- Prospective monitoring of various compliance indicators
Other
- Management of the group inbox
- Project support activities as required
- Administrative activities such as scheduling meetings and meeting minutes
- Updates to SharePoint sites
- Meeting attendance
- Preparation, Review and Distribution of compliance Newsletter
General
- Applies practical knowledge of job area typically obtained through advanced education and work experience
- Works independently with general supervision to achieve operational targets with direct impact on departmental results
- Problems faced are difficult but typically not complex, sometimes requiring understanding of broader set of issues
- May influence others within the job area through explanation of facts, policies, and practices
- Select jobs may have formal supervisory responsibilities for support employees
YOUR BACKGROUND:
â?¢ Excellent knowledge of English (MANDATORY) and German (ADVANTAGEOUS).
â?¢ Bachelor degree in a Life Science or Business, Advanced degree in a Life Science (PhD,MD) or Business (MBA) an advantage.
â?¢ 1+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred.
â?¢ Thinks beyond and maintains an external and strategic focus
â?¢ Builds bridges and helps teams develop collaboration
â?¢ Unleashes outcomes and creates an accountable work environment
â?¢ Ignites agility and instills personal flexibility in self and teams
â?¢ Inspires the future and ensures clarity around the strategy
â?¢ Cultivates talent and hires/coaches effectively
WHAT'S ON OFFER
â?¢ An initially 6 month contract at an internationally-renowned biopharma company.
â?¢ A varied job in a dynamic but stable environment with the opportunity for professional development.
â?¢ A competitive salary.
If this sounds like you, donâ??t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: Write an email.
À propos de l'entreprise
