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Electronic Submission Specialist Job

Eingestellt von Yoh

Gesuchte Skills: Support, Adobe

Projektbeschreibung

ELECTRONIC SUBMISSION SPECIALIST needed for a contract opportunity with Yoh's client located in Berkeley Heights, NJ.

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

  • Einsatzort:

    Berkeley Heights, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Medien/Design, Sonstiges

  • Skills:

    support, adobe

Yoh