Global Submissions Manager

Highly Competitive
  1. Permanent
  2. Publishing & Submissions
  3. United States
Cambridge, Massachusetts
Posting date: 30 Apr 2019
RA.KC.23015_1556634932

ProClinical are currently recruiting on behalf of a leading global pharmaceutical company that specialises in multiple therapy areas. They are currently looking to recruit a Global Submissions Manager to work in Massachusetts The organisation offers an excellent rate of pay and have a strong reputation as an excellent company to work for.

Job Responsibilities:

  • 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 Client 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 FDA's "Portable Document Format (PDF) Specifications" and Client's 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.
  • Other responsibilities as assigned.

Skills and Requirements:

  • Bachelor's degree or higher in a relevant technical or scientific field is required.
  • Minimum of 6 years of pharmaceutical industry, regulatory publishing/submissions management experience.
  • Working knowledge of Agency regulations and industry standards pertaining to regulatory operations is essential.
  • Demonstrated understanding of the drug development process is highly preferred.
  • Experience working within Regulatory Operations environment. Preferred experience in publishing and submission management.
  • Evidence of working with US and/or EU Regulatory Agencies supporting Regulatory Dossier review and approval processes. EU experience preferred.
  • Technologically savvy with the ability to quickly learn software applications and troubleshoot as needed.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Kevin Cassini at +1 215 531 5288 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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