DXC Technology Hiring Professional 2 Regulatory Publishing Pharmaceutical /Biotech /Diagnostic /medical device Apply Now
Job
Description:
7+ years of
Regulatory Publishing experience
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
Basic
Qualifications
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
Other
Qualifications
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
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