Regulatory Submissions Assistant Job

REGULATORY SUBMISSIONS ASSISTANT needed for a contract opportunity with Yoh's client located in Research Triangle Park, NC.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Regulatory submissions
- Electronic publishing

WHAT YOU'LL BE DOING:

- Responsible for document formatting support provided to GRA regulatory execs (Therapeutic Groups, Discovery Regulatory, NonClinical Regulatory and CMC Regulatory). Publish regulatory authority specific documentation for delivery to markets in which GSK does business using sophisticated, validated, purpose-developed electronic documentation software.
- Responsible for support of global CMC processes or systems used to support global CMC regulatory activities.
- Maintains knowledge of relevant regulatory authority rules and guidance associated with different formats of regulatory submissions.
- Responsible for on-time delivery of electronic and electronically prepared paper submissions for submission types ranging from major, original NCE or biological applications through to life cycle submissions required to maintain an application's registered status and fulfil regulatory obligations.
- Manages routine multiple project assignments/teams simultaneously with line manager support.
- Regular communication with line manager to help identify any documentation issues with business process impact

WHAT YOU NEED TO BRING TO THE TABLE:

- Experience with electronic publishing and strong knowledge of eCTD requirements.
- Five (5) years of experience with pharmaceutical documentation formatting would be ideal
- Document management experience or information technology experience with emphasis in submission/report publishing and project leadership.
- High proficiency in publishing tools such as Documentum, ISI eCTDXpress, Adobe Acrobat, and expert knowledge of WORD and EXCEL.
- Demonstrated organization skills and ability to work independently. Strong oral and written communication skills. Must be a self-starter and team player.
- Excellent attention to detail and commitment to deliver high quality output, even under pressures demanded by deadlines.
- Demonstrated ability to think flexibly in order to meet constantly shifting priorities and timelines.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W: CLINICAL

MONJOBJ2WSEMW

Ref:

SFSF: LS