CTG eCTD Specialist in Whippany, New Jersey
Title: eCTD Specialist
Job Number: 17205281
Come join us and grow your career with CTG! CTG has a new opportunity available with a global pharmaceutical and sciences client! Apply with CTG for this exciting opportunity!
Project Duration: Consulting Position, 12 months with possible extension
Project Location: Whippany, NJ
Job Title: eCTD Specialist
As an eSubmissions expert, the incumbent provides direct support to submission project teams, internal RA stakeholders and all functional disciplines responsible for developing and delivering components for submissions. Additionally, the incumbent performs hands-on daily submission compilation and publishing activities associated with preparation of various dossier types and safety reports, for both new product marketing applications and/or marketed product maintenance packages.
Incumbent is responsible for the overall quality of the assigned documents and dossiers which must comply with all internal best practices, meet global regulatory requirements, and facilitate the review and timely approval by appropriate regulatory authorities. As part of the submission compilation process, he/she carries out the technical review of the eCTD compliance of dossier-relevant R&D documents/reports.
The main objective of this function is to support the compilation of global dossiers and to deliver technically compliant submission documents/reports, which contribute to the development of submissions that meet the technical requirements and standards set by relevant health authorities. This is accomplished via the technical review of components for eCTD submissions ensuring the components/documents/reports are technically compliant (including the technical improvement of legacy documents/reports not meeting requirements), assigning submissions components to the appropriate submission location, applying an appropriate level of necessary navigational aids (e.g. inter-hyperlinks, bookmarks), and validating the output with appropriate tools.
The Submissions Specialist partners closely with Regulatory Affairs Managers/Liaisons, under the direct supervision of a Regulatory Submissions Leader (RSL) and/or RSMP Management to ensure: overall technical content of the submission and the quality of the dossier meets the (navigational) requirements of the reviewing health authority and is in alignment with established global business objectives, format meets all internal requirements.
The Incumbent executes all operational activities associated with compilation, publishing and distribution of submission components under the direct supervision of a Regulatory Submissions Leader and/or RSMP management. As part of the submission compilation process, carries out the technical review / technical improvement and verification of the eCTD compliance of dossier-relevant R&D documents/reports consistent with appropriate standards. This is achieved by enhancing the technical quality of submission relevant documents/reports and/or collaborating with authors. Diversity of submission types and complexity include all potential dossier types worldwide.
The individual is trained on relevant Health Authority requirements regarding (electronic) submissions and processes. He/She is highly responsible for applying all global regulatory guidance and regulations associated with the technical assembly and publication of submissions (paper, electronic and/or non ICH formats) with oversight from a RSL and/or RSMP management. Ensures achievement of submission milestone dates for assigned publishing support activities. Identifies and documents issues that risk the submission timelines and escalates the issues to the RSL and/or RSMP management to recommend appropriate resolution. .
• Minimum of 5 years in the pharmaceutical industry without a degree, or a BS/BA degree with 1-2 years in the pharmaceutical industry or a MS/MBA degree with no previous work experience (Relevant experience may be met via a combination of electronic data/document management, project management, computer systems or publishing software support, electronic document publishing and/or regulatory affairs.)
• Previous experience or knowledge of eCTD Module 1 DTD 3.3 and/or Advertising and Promotion (AdPromo) eCTD publishing a plus.
• Experience with document management or electronic publishing tools (such as PDF Fusion, EZsubs, Core Dossier, ISI Toolbox, Docubridge etc.). Must have an excellent working knowledge of databases and data structures (such as Lotus Notes databases, Oracle IMPACT, MS Access, SAS, etc.).
• Knowledge of drug development process and relevant SOPs is required along with an understanding of federal regulations, international standards (e.g. ICH), and regulatory guidance's as they pertain to the development and filing of e-submissions. The ability to interpret implications of these regulations, apply them to daily operations and to respond appropriately to questions from peers and cross functional professional staff is imperative.
• Must have an excellent working knowledge of word processing, document management, and desktop publishing software packages, including hands-on knowledge of various document types, authoring tools and file formats (such as MS office templates, PDF files, SAS program/transport files, XML program code, etc.).
• Strong communication and interpersonal skills are needed to interact with global document authors and their support staff across international sites and across different functional departments. Multi-cultural sensitivity gained from some direct international experience is recommended.
• Good written and oral English communication skills are required.
No third party resumes will be accepted
Drug testing and/or other employment-related inquires may be conducted
All interested individuals MUST be able to work on a W2 Tax basis (no C2C or third party vendors)!
Candidates must currently reside in USA or Canada
CTG is an Equal Employment Opportunity employer
CTG is an E-Verify Company
To be considered for this opportunity, please apply directly through our website by clicking the link below or email your Word version resume and salary requirements to email@example.com.
CTG is the most reliable IT services provider, built on 50 years of meeting our commitments to make technology work for clients and deliver real business value. CTG provides industry-specific IT strategy, services, and solutions that address the business needs and staffing challenges of clients in high-growth industries, including major technology companies, large corporations, and government entities located in North America and Western Europe.
CTG's greatest asset is its people, and as such we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work Company by Modern Healthcare (since 2013) in North America, and a Best Places to Work Company in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Documentation Management