Clinical Research Document Specialist II (19-00955) – NJ – East Hanover


Job Purpose  

Perform assessment, quality control and publishing of NIBR scientific documents to ensure consistency with source data and to achieve the technical quality to comply with internal and external guidelines and requirements. Collaborate with external service providers as related to areas of responsibility. Collaborate to support timely compilation of high-quality submissions for Global Health Authorities.  

Major Accountabilities 


  1. Perform source data verification (SDV) and technical (Novstyle) quality control (QC) of NIBR submission documents (simple to medium complexity) to ensure both content and format fulfil requirements. Collaborate with globally located NIBR scientific personnel to ensure finalization of the documents, according to timelines and quality requirements.
  2. Compile, integrate and publish applicable NIBR documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible author(s).
  3. Work with external consultants (vendors) to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partner with the respective document author(s) to reconcile findings and finalize the submission document(s).
  4. Resolve technical document or workflow issues as applicable on the documents being processed.
  5. Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of Client' document management systems.
  6. Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
  7. Collaborate with Submissions Management team on specialized projects, to support key submission deliverables.
  8. Collaborate to provide metrics, KQIs and KPIs.
Key Performance Indicators 


  • Completion of an adequate number of regulatory documents (taking into account complexity and size)
  • Timeliness of deliverables, such that both individual document review KPIs are satisfied and overall project timelines are adhered to.
  • Proactive and collaborative communication with key stakeholders based on feedback from internal colleagues and customers.
  • Adherence to Client Values and Behaviors and code of conduct.


Job Dimensions


Number of associates: None
Financial responsibility:
(Budget, Cost, Sales, etc.)
Impact on the organisation:                               Timely finalization of high quality regulatory documents reflective of source documents and format requirements, to ensure quality requirements of NIBR contributions to submissions are met. 


Ideal Background 


Education (minimum/desirable): Undergraduate degree preferably in a scientific discipline  or equivalent work experience
Languages:              English fluent (oral and written)
Experience/Professional Requirement:          
  • 3-5 years of relevant work experience with electronic document management systems and document review.
  • Basic understanding of clinical and nonclinical information contained in a submission dossier.
  • Demonstrated ability to work successfully within a matrix environment and influence cross-functional teams.
  • Flexible and detail oriented approach to documentation management, as appropriate.
  • Experience with and ability to understand compliance practices, which include GxPs and Standard Operating Procedures.
  • Strong oral and written communication skills and customer service mindset.
  • Proficient in Microsoft office programs (e.g. MS Word).
  • Self-starter with a proven ability to prioritize work, multi task, display customer centricity and manage time appropriately, in a fast paced/high volume environment.

Source: Job Diva – Job Listing

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