Records Management and Safety Compliance Coordinator

Janssen Inc., Canada is currently recruiting for a Records Management and Safety Compliance Coordinator in Toronto ON. Records Management and Safety Compliance Coordinator will assist the department in maintaining paper and electronic documents to applicable local and global SOPs as well as to Health Canada guidelines. Some of the responsibilities may include providing general administrative support for the department and involvement as a coordinator in Drug Safety compliance activities, as well as records management and support with duties for Drug Safety paper case files and electronic records management. The records management and support duties (for both paper and electronic records) include the entire RQMS (Regulatory Affairs, Quality Assurance, Risk Management and Drug Safety) division based on business needs. **Major Duties & Responsibilities**: - Performs various records management related responsibilities such as maintaining records, extracting, sorting, numbering, batching, and filing tax returns and related correspondence - Maintain e-update of records into GREATS - Support electronic and/or paper documentation of departmental training records completion, collection and archiving - Support compliance tasks in respect to records management and compliance communication coordination - Locate, gather and withdraw file material or information from records - Enter document identification codes into systems to determine locations of documents to be retrieved - Place materials into storage receptacles, such as file cabinets, boxes, bins, or drawers, according to classification and identification information - Assist in off-site records archiving process - Assist with the migration of the applicable Drug Safety and Surveillance documents to the designated Drug Safety and Surveillance GxP repository - Assist in RQMS records management activities under direction of Janssen Canada Records Manager, as required; this may include records support for divestitures, litigation, and integration - Member of Janssen Canada Records Management Center of Excellence - Preparation of extracts to be used by Drug Safety Associates (DSAs) for Canada Vigilance Adverse Reaction Online Database (CVAROD) reconciliation - Assist/Lead in the distribution and allocation of extracts to DSAs for case processing - Data entry, tracking and update of case numbers within the Health Canada Reconciliation Log to ensure compliance with Pharmacovigilance requirements - Provision of data and performance of allocated tasks related to the Health Canada Reconciliation Log as required - Establish priorities in alignment with filing workflow **Qualifications** - Minimum Bachelors Degree in Science or related field - Minimum 1 year experience with GxP compliance for files and records (paper and electronic) preferred - Prioritization and organization of workflow activities in a team environment - General working knowledge of document management systems - Superior level of attention to detail and follow instructions - Ability to work in a team environment - Excellent problem-solving abilities - Ability to work within tight deadlines - Fluent in English; Proficient skill level in Adobe Acrobat, Microsoft Word and Microsoft Excel **Working Conditions**: - Head office in Toronto flex schedule office (min 3 days onsite and 2 days remote; role often requires more days onsite due to filing hard copies) - A requirement for physical exertion (lifting or moving objects >25lbs/10Kg in weight) - Requirement for long periods of sustained visual focus and concentration - Expectation to use a computer on an almost continuous basis, every day - Work may require long periods of standing, bending, lifting, and carrying of files or other material; or may require recurring lifting and carrying of files or cartons of moderate weight (up to 22 Kg) on occasion. Janssen Inc. is based in Toronto, Ontario and supports a Flexible Work Arrangement to provide flexibility options for individual needs to support when, where and how we work. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. **Primary Location** Canada-Ontario-Toronto-19 Green Belt Drive **Organization** Janssen Inc. (7710) **Job Function** R&D **Requisition ID** 2206054874W