Description:
This section focuses on the main purpose of the job in one to four sentences.
Under limited supervision responsible for the implementation of regulatory strategies, and resolution of issues pertaining to documents/ packages for regulatory submissions.
Produces and evaluates technical and scientific data necessary for regulatory submissions. Assists in the implementation and delivery of new or upgraded systems and processes in support of companies products.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
The incumbent will perform other duties assigned.
Document all system related issues, and identify resolutions
Document complex processes and create and manage documentation related to validated systems
Participate in identifying solution to meet requirements for systems
Participate in system upgrades to assure integrity of data is maintained
Assure adequate access and functioning of system tools and version upgrades
Provides expertise in ongoing maintenance of electronic record receipt and submission to regulatory authorities
Participate as an active team member and provide expertise to project teams as required
May verify the maintenance of support systems, libraries and dictionaries
Maintain awareness of regulatory requirements and evaluate potential impact to company
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Detail oriented
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Written and verbal communication skills - Knowledge of applicable regulations
Excellent organizational skills and ability to support multiple projects
Ability to contribute to multiple projects from an operations perspective
Work independently with minimal direct supervision
Strong negotiation and collaboration skills
Manage multiple projects and deadlines
Ability to identify compliance risks and resolve or escalate when necessary
Experience in addressing complex problems or processes
Include the education and experience that is necessary to perform the job satisfactorily.
Bachelors Degree or country equivalent with a minimum of 5 years in a regulated environment. Scientific or related discipline would be an advantage.
Notes:
Shift - 1
VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status