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Electronic Submission Specialist Job
Eingestellt von Yoh
Gesuchte Skills: Support, Adobe
Projektbeschreibung
THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:
- Regulatory submissions
- IND, NDA, MAA, CTD
- Electronic Document Management Systems
WHAT YOU'LL BE DOING:
- Support Regulatory Affairs personnel in the coordination, preparation, and submission of INDS/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format.
- Responsible for the creation and compilation of quality Regulatory submissions and life cycle management submissions.
- Planning, preparing, tracking, and archiving regulatory documents and submissions.
- Responsible for the creation, assembly, and publishing of both major and routine global paper and electronic submissions, including MAAs/NDAs, INDs, 510(k)s, Annual Reports, Periodic Safety Reports, Supplements, Amendments, Variations, Renewals, etc.
- Responsible for maintenance of all Regulatory and Health Authority correspondence (distributing, and archiving into electronic document management system) within specified time frames.
- Verification of regulated documents via workflows within Clients's electronic document management system (eSub LiveLink).
- Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
- Liaise with functional source areas (clinical, nonclinical, cmc, regulatory) to ensure documents are compliant with authoring style guide.
- Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications
- Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
- Represent Global Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
- Close interaction with authoring community to track availability of deliverables.
WHAT YOU NEED TO BRING TO THE TABLE:
- BA/BS Degree, two (2) years of pharmaceutical industry experience, prior Regulatory Operations experience preferred
- Knowledge of IND, NDA, MAA, CTD, NeeS requirements and guidelines, both paper and electronic
- Technical knowledge of electronic publishing systems and software
- Proficiency with MS Office Suite and Adobe Acrobat applications
- Knowledge of FDA procedures/guidance's regarding electronic submissions
- Knowledge of Electronic Document Management Systems
- Self-starter with superior time management skills, and ability to work independently or in teams
- Strong attention to detail
OPPORTUNITY IS CALLING. APPLY NOW!
RECRUITER: Hannah Cihlar
Yoh, a DayJ2W: SCIENTIFIC
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Ref:
SFSF: LS
Projektdetails
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Einsatzort:
Berkeley Heights, Vereinigte Staaten
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges