DXC Technology Recruitment 2021. DXC Technology Notification full detailes below.DXC Technology is the world’s leading business transformation company, helping customers harness the power of innovation to thrive on change.
Important Vacancy details:
- Post Name: Professional 2 Regulatory Publishing
- Education:Bachelor’s degree in life sciences specialty (pharmaceutical /biotech /diagnostic /medical device) preferred
- Experienced:7 years
- Location:Hyderabad, AP IN
- Salary: NA
- Openings: NA
Job Description: Hiring For Professional 2 Regulatory Publishing in DXC Technology!
Managing & motivating the team towards a common goal and keep them focused
• Ensuring that service levels are met and strive to exceed service levels
• Planning and managing training and ensure staff are adequately trained
• Perform submission publishing, assembly and distribution activities.
• Performing submission readiness checks.
• Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
• Performing final technical quality review and technical validation (eCTD)
• Notifying relevant stakeholders that the file is ready for approval
• Compiling SAS and other datasets and non-PDF files.
• Dispatching submission to the relevant authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority;
• Knowledge of FDA / ICH guidelines, Life Sciences & Pharmaceutical industry
• Knowledge of health authority procedures / guidance regarding electronic submissions
• Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders
• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
• Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence
• Ensuring ongoing coaching of team members and ensure personal development plans are in place for all team members
• By continually up-grading domain knowledge
• Following company rules and standard operating procedures.
• Adhering to all Security Policies and Procedures
• Promoting a positive and professional image of the team always.
• Need to abide to the existing Information Security Policies and Procedures
- Bachelor’s degree in life sciences specialty (pharmaceutical /biotech /diagnostic /medical device) preferred
- Three or more years of regulatory publishing experience
- Experience working with standard publishing tools and applications
- Good organization and time management skills
- Communication, presentation and facilitation skills
- Ability to write reports, business correspondence, and project plans
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, and governmental regulations
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
Selection Process: The selection will be onthe basis of Interview.
How to Apply : Click here for full details and Apply Online