Assistant Manager Publisher Jobs

Assistant Manager Publisher

Client location- NJ

Remote

Vertical- Life Sciences

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

Responsibilities

• 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

Qualifications we seek in you!

Minimum qualifications

• 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.

Preferred Qualifications

• Proven rich experience in Pharmacy Regulatory Affairs