- Project Management
- Project Management skills
- Team management
- Veeva Vault
We are looking for Publishing Manager - Remote / Telecommute for our client in Jersey City, NJ
Job Title: Publishing Manager - Remote / Telecommute
Job Location: Jersey City, NJ
Job Type: Contract
Pay Range $35hr - $38hr
- 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.