Senior Manger Publisher Jobs

Title: Senior Manager/Assistant– Publisher

Duration: 11 months

Location: Remote

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

Responsibilities

• Performing final technical quality review.
• Managing the operations and team
• Dispatching submission to the relevant authority ((eCTD/CTD/NeeS/Paper) or affiliate so that affiliate can dispatch to authority;
• Taking care of administrative responsibilities of team
• Team management and team engagement
• Project & resource management
• 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;
• Publishing and performing technical validation (eCTD/CTD/NeeS/Paper) for the Asia Pacific region and US Submissions.
• Co-ordinate with client/stakeholders
• Project Management skills
• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.

Minimum qualifications

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

Preferred Qualifications

• Proven rich experience in Pharmacy Regulatory Affairs

Thanks & Regards

Contact:+1 (732) 452 1006 || EXT:553

Email ID: [email protected]