• Authoring and Quality Assurance of Project Activities

• Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures

• Marking /QC/Review and/or editing of pertinent documents such as:

• Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH)

• Protocol and results summaries to support clinical trial disclosure commitments

• Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP

• Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs

• Ensure to abide with Client process

• Educational qualifications: A minimum of a scientific graduate degree in life sciences.

• Good knowledge of regulatory requirements or guidance pertinent to the service line.

• Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills

• Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.

• Person should understand comprehend protocol and clinical study report from disclosure perspective.

• Good understanding of clinical trial disclosure fundamental

• Core competencies for this role include ability to demonstrate:

• Analytical capabilities with scientific and clinical data

• Professional working environment

• Ownership of the work allocated

• Commitment to highest quality outputs, including high attention to detail

• Enthusiasm and pro-activity

• Effective team working

• Ability to build rapport/ relationships with project-specific client colleague