Submission Specialist

18 Feb 2021
27 Feb 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Advanced Clinical LLC seeks Submission Specialist in Deerfield, IL.

Prepare global submissions. Review regulatory issues with supervisor, as necessary, and assist in the negotiation of submission issues with agency personnel. Prepare local paper submissions to FDA . Complete all on time submissions to all applicable reporting destinations. Generate, review, and transmit to all schedule reports to Global Health Authorities including but not limited to FDA European Agencies, Health Canada, etc. Generate CIOMS I form, 3500 FDA MedWatch Form or similar to global partners based on defined timelines. Monitor the safety database for failed submissions. Prepare safety information for submission to local PV representatives. Follow-up with Local Safety Manager to ensure on-time submissions and request details on late submissions. May provide training and support to newer members of the submission team. Collaborate with Safety Data Management, Compliance and Business Management and local PV representatives to maintain accurate reporting rules. Responsible for review and maintenance of reporting rules within the Argus Safety Database. Perform oversight of the Submissions Mailbox. Telecommuting permitted.

Requires Bachelor's Degree in Regulatory Affairs, Biology, or a related field plus 4 years of experience in the job offered or related role. Requires 4 years of regulated environment experience in pharmaceutical, biotechnology, or CRO industry; 2 years of experience with global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance; 2 years of experience with ARGUST Safety Database Knowledge; 2 years of experience with medical device submissions; 2 years of Global Drug Safety Case processing experience.

Must also have authority to work permanently in the U.S. Applicants who are interested in this position may apply at Job ID: 80469 for consideration.

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