24 Nov

Clinical Regulatory Publisher Jobs Vacancy in Diversity Direct Basking Ridge

Position
Clinical Regulatory Publisher
Company
Diversity Direct
Location
Basking Ridge NJ
Opening
24 Nov, 2017 30+ days ago

Diversity Direct Basking Ridge urgently required following position for Clinical Regulatory Publisher. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Clinical Regulatory Publisher Jobs Vacancy in Diversity Direct Basking Ridge Jobs Details:

Thus client, a growing firm is in need of a Clinical Regulatory Publisher for the following project:

Duties

  • Support preparation of key submission critical clinical documents - the Clinical Study Protocol (CSP), Global Investigator's Brochure, Clinical Study Report (CSR) and Clinical Summaries.
  • Collaborate with functional area stakeholders (eg, Clinical Operations, Regulatory Operations, Data Management, IT etc.); along with the Medical Writer(s) to improve cross-functional processes and working standards as they relate to clinical regulatory document publishing, submission readiness and cllent document standards.

This individual should have:

  • An understanding of the clinical development process and the clinical regulatory document lifecycle,
  • Familiarity with good clinical practices (GCP) and developing global and regional Standard Operating Procedures (SOP)s and Standard Operating Instructions (SOIs),
  • Knowledge of eCTD Submissions (ie IND, NDA, MAA and CTA etc.),
  • Knowledge of electronic document management systems (EDMS);
  • Knowledge of report and submission publishing systems/software
  • Minimum years of experience: 3-5 years in Clinical Regulatory Submissions (ie, submission level publishing) and Clinical Regulatory documents (ie, report level/document level publishing).
  • Education requirements: Bachelor's degree is preferred
  • Experience working within a matrix organization.

The primary responsibilities of the Clinical Regulatory Publisher:

  • Provide clinical document support to Medical Writing and Clinical Safety and Pharmacovigilance (CSPV); troubleshoot and repair document formatting and publishing (ie Word and PDF);
  • Coordinate with Lead Medical Writers and Clinical Study Delivery Leads to collect and assemble supporting documents for the Clinical Study Report (CSR Appendices);
  • Perform document publishing activities on final CSR (CSR Synopsis, CSR Body, CSR Appendices, Tables Listing and Figures (TLFs);
  • Ensure correct and current clinical template usage;
  • Ensure submission readiness of all clinical regulatory documents concentrating on styles, format, structure, navigation, adherence to the client's House Style Guide, Clinical Publishing SOP and Regulatory Operations eSubmission Ready Document Standard;
  • Perform independent publishing QC on published reports, complete appropriate checklists and/or provide assessments for the activities around the quality of document publishing and submission readiness of source documents;
  • Attend clinical document kickoffs and/or project team updates with Associate Director MW Therapeutic Area (TA) Lead and/or Lead Medical Writer to communicate document publishing activities, coordinate document timelines and gain an understanding of document handoffs;
  • Work with Lead Medical Writer on updates to all clinical documents to support submission readiness activities in Word source documents and final published PDF outputs;
  • Provide document support to Clinical Safety and Pharmacovigilance (CSPV) development safety update reports (DSURs) and periodic adverse drug experience reports (PADERs);
  • Serve as the liaison between Medical Writing and Regulatory Operations.
  • Experience with Toolbox for submission readiness activities such as bookmarks, hyperlinking, pagination etc.;
  • Strong MS WORD background for managing styles, formatting, TOCs and cross-references within DS core templates (Accenture's StartingPoint templates);
  • Working knowledge of eCTD templates;
  • Understanding of Regulatory requirements on document structure and navigation (FDA, ICH);
  • Understanding of CSR structure and content (ICH E3);
  • Experience in electronic document management systems (EDMS - Veeva Vault) and publishing software (docuBridge);
  • English language written and verbal communication skills;
  • Ability to organize, prioritize and work within a rapidly changing environment;
  • Able to work independently (with some guidance from direct manager anticipated);
  • Ability to work collaboratively across different cultures, time zones and experience levels;
  • Ability to work on special projects as they are assigned by the Manager or Department Head
  • Minimum years of experience: 3-5 years in Clinical Regulatory Submissions (ie, submission level publishing) and Clinical Regulatory documents (ie, report level/document level publishing).
  • Education requirements: Bachelor's degree is preferred.

Skills Required:

  • CLINICAL REGULATORY
  • DOCUMENT MANAGEMENT
  • MEDICAL WRITING
  • DOCUMENT MANAGEMENT SYSTEMS
  • REGULATORY DOCUMENTS

Additional:

  • EDMS
  • FDA
  • ICH
  • NDA
  • PUBLISHER
  • PUBLISHING
  • ACROBAT
  • CLINICAL DOCUMENTS
  • CLINICAL OPERATIONS
  • CLINICAL SAFETY
  • CLINICAL STUDY
  • DATA MANAGEMENT
  • E-CARRIER
  • EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
  • GCP
  • LEADS
  • LIAISON
  • MS WORD
  • OPERATIONS
  • PDF
  • PHARMACOVIGILANCE
  • SOP
  • THERAPEUTIC
  • WORD

Minimum Degree Required:

Bachelor's Degree

Job Type: Contract

Required education:

  • Bachelor's

Required experience:

  • Clinical Regulatory Submissions: 3 years
  • clinical regulatory document lifecycle: 3 years
  • electronic document management systems (EDMS): 3 years
  • Knowledge of eCTD Submissions (ie IND, NDA, MAA and CTA: 3 years


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