Kelly Services Regulatory Submission Specialist in Gaithersburg, Maryland

Kelly Services is seeking a Regulatory Submission Specialist for a one-year assignment in Gaithersburg, MD. The Regulatory Submission 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 as well as your responses to the prescreen questions below.

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.

Prescreen Questions:

  1. How many years of experience do you have with publishing eCTD submissions?

  2. When was the last time you published eCTD submissions?

  3. How many eCTD submissions have you published in past 6 months?

  4. What type of eCTD submissions have you published?

  5. Which modules of an eCTD submission have you published?

  6. Have you used gateways to submit eCTD submissions?

  7. What publishing tools have you used?

  8. Have you published and submitted IND AEs (Adverse Events)?

  9. Have you published and submitted Promo submissions to FDA?

  10. Do you have experience with document formatting/document publishing?

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 relevant

projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help

advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000

scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world

a 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 kellyservices.com and connect

with 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 is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.