1+ months

Temp to perm Global Submissions Manager-eCTD, edms, Global submissions required

Kelly Services
Cambridge, MA 02238
**Seeking a Regulatory Global Submissions Manager for a 12 month temp to hire role in Cambridge, MA.**

OBJECTIVE:The Submission Management role supports all operational activities pertaining to the preparation of documents as part of a Marketing Authorization MA Application. This includes maintaining updates to the MA Content Plan, including changes to scheduled deliverables and contributing functional areas.Responsible for logistics, preparation, quality check, and delivery of regulatory submissions in accordance with agency requirements and company standards. Acts as direct liaison with Global Regulatory Affairs staff and contributing departments to facilitate effective management of submissions.Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance. Sets priorities within area of purview and ensures adequate workload balance through interactions with other team leads and management.The role is responsible for ensuring MA documents are submission-ready and meet internal and regulatory standards for electronic submissions, and that documents properly processed in VBUs Electronic Document Manage System EDMS . This requires regular engagement with MA stakeholders, actively tracking progress of MA components, and supporting access to relevant systems. The role will conduct QC of submission-ready documents and participate in the QC of draft/final submission outputs for the MA. All activities will be carried our according to applicable regulatory guidelines as well as relevant VBU SOPs.

ACCOUNTABILITIES: Performs report-level publishing and submission-ready activities for MA in accordance with internal standards and regulatory requirements. Completion of accurate metadata in the EDMS Word Documents Adherence and application of styles and standards. Use of Word functionality to auto-generate required document navigation bookmarks, hyperlinks, Table of Contents, List of Tables/Figures/Appendices Verification that file renders correctly to PDF PDF Documents. Creation of bookmarks and hyperlinks For PDFs with bookmarks and hyperlinks already in the document, verification of the accuracy of bookmarks and hyperlinks. Audit of bookmarks and hyperlinks using TRS/ISIToolbox Application of correct document properties. Verification that PDF meets technical specifications as outlined in FDAs Portable Document Format PDF Specifications and Electronic Format Standards for Submission Documents. Conducts QC of MA submission documents to ensure submission-ready standards are met. Maintains MA Content Plan including changes to timelines and stakeholders. Provides visibility to progress using reports and dashboards. Incorporates changes to binders/documents including document metadata, target dates, and creation/addition/deletion of binders/documents/placeholders. Interfaces with MA stakeholders to ensure sufficient awareness and understanding of MA document requirements including eCTD principles and lifecycle management to enable valid submissions, and to ensure the creation of global submission-ready documents and effective management of those documents in the EDMS. Provides effective and timely system support. Participates in the QC of draft and final published MA submission output to ensure compliance to regulatory agency standards and requirements for electronic submissions. Interprets industry or health authority guidance related to submissions and communicates changes. Executes day-to-day activities for MA. Supports the planning and execution of MA project.


**For immediate consideration, please send your resume to**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll 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 careerconnect 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 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.


Posted: 2019-07-22 Expires: 2019-09-21

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Temp to perm Global Submissions Manager-eCTD, edms, Global submissions required

Kelly Services
Cambridge, MA 02238

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