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eCTD Submissions Specialist

Kelly Services

Gaithersburg, MD
Job Code:
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Job Details

Job Title eCTD Submissions Specialist

Jobid US33MXGR_BH1442822

Location: Gaithersburg, MD, 20898, USA

Description Kelly Services is seeking an **eCTD Submissions** **Specialist for a one-year assignment in Gaithersburg, MD** . The Specialist will be responsible for end-to-end document and submission publishing, which includes planning, compiling, publishing, delivering and archiving of regulatory submissions in accordance with health authority standards and customer procedures as well as provide support to project teams, external partners and stakeholders on topics related to document and submission publishing in accordance to Global Regulatory Operations Operating Model.

Essential Requirements:

• University degree or equivalent experience in life sciences or technical field

• Minimum 2 years hands-on experience with publishing eCTD submissions

• Demonstrated ability to work in accordance with processes

• Demonstrated ability to work collaboratively in a global team environment and to have good project management skills

• Demonstrated ability to work independently and to set and manage priorities, resources, performance targets and project initiatives in a global environment

• Comprehensive knowledge of Microsoft Office and Adobe Acrobat applications

• Excellent English written and verbal communication skills.

Desirable Requirements:

• Experience of system administration for validated applications within a regulated environment

• Experience in pharmaceutical/medical industry and/or knowledge of the drug development process, product life-cycle and contents/formatting of regulatory submissions

• Experience as document and submission publisher including knowledge of regulatory publishing tools (e.g., eCTDXpress, FirstDoc, ISIToolBox)

• Knowledge of submission compilation, publishing, approval processes, tools and standards

• Ability to thrive in a rapid paced environment

• Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business

• Good problem and conflict resolution skills.

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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