Job Title: Publishing Manager

Loc: Remote

Exp: 5 Yrs

Job Description:

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

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

Comments for Suppliers:

Capped at 1650 hours over 11 months. If the contractor leaves before the contract end date, then the hours will be averaged to 150/month and any hours exceeding this average will be adjusted in the last month and payment made accordingly

Interested's kindly share your resumes to gowtham@quantumbricks.io

Job Type: Contract

Salary: $25.00 - $30.00 per hour

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Princeton, NJ: Reliably commute or planning to relocate before starting work (Required)