Job Description

Job Summary The Associate Electronic Submissions Specialist is responsible for building and publishing electronic submissions to Drug, Biological, and Device Regulatory Agencies. This position will routinely collaborate with Regulatory Affairs Specialists and their manager to establish a project schedule that supports the submission deadlines. The Submission specialist will review and understand FDA electronic submission guidance's and will review each document and submission for compliance, advising on the quality requirements of the electronic documents. This position is able to correctly place files within the XML backbone, provide naming conventions, build TOCs and hyperlinking as well as being a primary user for the operation of the SDMS, eCTD manager and Global Submit validation software. The submissions will range in size from single documents to hundreds of documents in a submission and will work with more senior publishers on more sizable complex submissions which can include clinical study files. This position will correct issues arising from the validation. Errors in the submissions can result in a submission being rejected electronically or having the entire submission refused for quality reasons, with severe impact to the company. The Associate Specialist will provide status updates to leadership and/or escalating where needed to achieve desired outcomes.

Salary Range: $23.45-$32.00 per hour

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

Responsibilities

The position is responsible for:

• Submission publishing and compiling

o Adheres to established Quality/Regulatory Procedures

o Possesses basic understanding of industry standards and publishing tools required to perform job responsibilities

o Accountable for accomplishing objectives/goals and takes initiative to improve performance to align with expectations

o Prioritizes projects effectively to execute publishing tasks according to established timelines

o Holds high standards of publishing quality

* Collaborates effectively in a team environment ensuring not only individual tasks, but team and department objectives are achieved as well

o Cultivates effective working relationships in an effort to identify and gain sufficient understanding of customer needs

o Escalates issues appropriately to immediate manager, clearly articulating barriers to immediate manager for guidance on sensitive situations

o Actively looks for opportunities for continuous improvement, or enhancements, and provides suggestions to improve current processes

* Ensures immediate manager is aware of activities and current status/progress

* Manages individual workload within their realm of authority and autonomy

* Projects professionalism, respect, and a cooperative demeanor at all times

* Performs additional tasks and duties as assigned by RA Leadership

Requirements

* A BS/BA is required with some experience in the Pharmaceutical Industry

* Proficient working knowledge of Microsoft Programs and Adobe Acrobat Applications

* Detail-oriented and effective organizational skills

* Strong verbal and written communication skills

* Strong teamwork skills; self-motivated; strong work ethics

* Ability to maintain confidentiality

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

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