Job Posting for Publishing Manager at QuantumBricks Inc
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)
Salary.com Estimation for Publishing Manager in Princeton, NJ
$77,910 to $102,323
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