Job Title: Regulatory Affairs Specialist II Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid... projects from Concept through Commercialization. Review pre-clinical, and clinical protocols and associated reports to be used...
Job Title: Senior Regulatory Affairs Specialist Job Location: Hyderabad, Telangana, India Job Location Type: Hybrid.... Preparation of document packages for international regulatory submissions from all areas of company, internal audits...
Job Title: Regulatory Affairs Specialist Job Location: Hyderabad, Telangana, India Job Location Type: Remote... of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent...
possible approvals of clinical trials applications. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility... and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions...
in user experience and report quality. Define and document technical standards, best practices, and data governance policies... testing, patient data from clinical care, HL7, FHIR, and/or clinical trial data management Professional Certifications...
, support, and coaching as required Strong working knowledge of TMF, eTMF and clinical document management systems, preferably... lives. Read more: . This is a supervisory position overseeing a team of eTMF Specialists responsible for document upload...
, especially related to training, document management, records management, internal auditing, and KPI reporting. Responsibilities..., including but not limited to periodic SOP reviews, change control, document management system (eQMS), control of records...
Department - Clinical Reporting Unit Does your motivation come from challenges and working in a dynamic environment... across all phases including but not limited to preparation of Protocols, Clinical Trial Reports (CTRs), non-interventional study reports...
lives. Read more: . Collaborate with clinical stakeholders to understand their reporting and analytics needs aligned... a "first time right" approach. Test developed reports, document results, and provide peer review support as needed. Adhere...
. A Day in the Life Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing.... Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop...
. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop... and routine matters. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal...
. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop... and routine matters. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal...
and strategies and working in a team environment with all organizational departments. Preparation of document packages... authorizations for assigned projects. Preparation of document packages for international regulatory submissions from all areas...
. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop... and routine matters. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal...
. Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects. Develop... and routine matters. Document, consolidate, and maintain oral and written communication with health authorities Prepare internal...
Software (Principal RA) is responsible for the coordination and preparation of regulatory plans and document packages... Intelligence domain. At Philips MRI the Principal RA cooperates closely with Product Development, Clinical Science and Marketing...
, Clinical Development Job Location: Bangalore, India Reporting to: Group Leader of Small Molecule Bioanalytical Laboratory... and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing...
to Regional Manager The core responsibilities are : 1. Professional Customer User Training using the defined scope document... and Support Specialist. 2. Understand & Resolve Customer Queries in a timely manner with proactive escalation 3. Ensuring...
Specialist to resolve quality and efficiency issues that may occur on any given project. Years of Experience: 2-4 years... is required in the following areas:Medical collections (Medical Collections Specialist II preferred), billing and/or claims experience...
Specialist to resolve quality and efficiency issues that may occur on any given project. Years of Experience: 2-4 years... is required in the following areas:Medical collections (Medical Collections Specialist II preferred), billing and/or claims experience...