Aerialist Job Description Sample
Manager – Submission Publishing Technical Specialist
As a memberof the VMRD Document Management team, the candidate selected for this position will work closely with Regulatory Affairs Managers and other scientific technical team members to manage the scheduling and processing of electronic (and sometimes hardcopy) submissions to US regulatory agencies (e.g. FDA, USDA, EPA). Processing of submissions includes: the dossier design and document/component sourcing phase > compilation or assembly of documents > quality check > final publishing > submission to regulatory agency > archive.
Specific responsibilities for this position include:
Coordinate with various project teams to assist/manage submission design and document sourcing
Coordinate with Regulatory Affairs Managers to ensure that all submission requirements and timelines are mutually understood and in line with corporate standards and deadlines for dossier delivery
Assemble and deliver high quality electronic (and sometimes paper) submissions to tight deadlines using the appropriate submission publishing systems and processes
Maintain an expert level of proficiency with submission publishing/archiving systems and tools and adhere to the appropriate use with respect to assigned tasks, such that regulatory compliance is preserved.
Provide training for these systems and tools to contractors and other internal staff as needed and may participate on industry wide working groups to improve these systems/tools.
Responsible for the electronic archiving of submission documents including component documents (e.g. clinical study protocols and reports). Makes technical decisions related to the categorization and handling of specific submission documents, especially with respect to how these are categorized and attributed within the electronic document management system.
Participate in or lead local/global departmental activities such as process improvement review teams, training, and team building as required, and performing other duties as agreed with line manager
May manage (direct or indirect) other submission publishing or document management staff.
EDUCATION AND EXPERIENCE:
- Degree or equivalent experience (BS, BSc, BA, MS/MA)
- Degree in Information Management, Library Science, or similar program
2 or more years of comprehensive experience working within an animal or human health R&D business function in a submission publishing or related regulatory specialty or support function
High level of IT literacy
Strong knowledge and experience with electronic document management systems and processes, specifically with those used for document authoring, review/approval and archiving
Experience managing and publishing US (FDA/CVM and USDA/CVB) and/or centralized European (EMA) electronic submissions
Intermediate to advanced user knowledge of Adobe Acrobat and Debenu Aerialist or ISI Toolbox
Excellent written and verbal communication skills are essential, including the ability to interact with a wide range of internal and external customers at all organizational levels
Proven ability to meet tight deadlines with little lead time – can prioritize tasks very effectively in a busy work environment
Strong attention to detail and ability to adhere to high quality standards
Works very effectively on teams and can perform well under limited direct supervision if necessary
Hands-on experience using a document management system for large scale/enterprise use (e.g. Veeva Vault) or similar system
Hands-on experience using the FDA's eSubmitter tool and USDA/CVB's NCAH Portal for compiling electronic Animal Health submissions
Hands-on experience using the FDA's WebTrader application for electronic submission transfer
Hands-on experience using an electronic AS2 gateway for transmittal of electronic regulatory transmissions to FDA
Knowledge of the VneeS electronic submission format (European Veterinary Submissions)
Prior people management experience a plus
Other Desirable Attributes:
Self-directed – can work with little/no direction to provide solutions/decisions for issues
Goal-oriented, strong desire to achieve and exceed expectations, consistently meets commitments
Excellent organization skills
Proven ability to lead or work on several simultaneous projects or activities
Maintains a strategic outlook – has desire and ability to anticipate and plan for future change
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at email@example.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
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