Publishing Manager - Remote / Telecommute

We are looking for

• The Role demands an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process-driven environment.

• Managing the operations and team.
• Taking care of administrative responsibilities of team.
• Project & resource management.
• Team management and team engagement.
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and US Submissions.
• Performing final technical quality review.
• Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
• Performing post-submission processing activities such as receiving acknowledgment 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.
• Co-ordinate with client/stakeholders.
• Project Management skills.

• B. Pham/M.Pharm/Science Graduate.
• In-depth working knowledge of ECTD/CTD/NEES/Paper types of submission, industry-standard publishing systems.
• Veeva Vault Experience.
• Effective time management and organizational skills.
• Effectively communication.
• Flexibility to adapt to a changing environment.
• Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, Docubridge, etc.