Responsibilities
The Role demands for a guide Publisher with proven ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to
• Performing final technical quality review and technical validation (eCTD/NeeS) for US, LATAM and Canadian Submissions.
• Performing final technical quality review and technical validation (eCTD/NeeS)
• Dispatching submission to the meaningful authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority;
• Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; presenting submission receipt to key partners;
• Collecting submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
Qualifications we seek in you
Minimum qualifications
• B. Pham/Science Graduate
Preferred qualifications
• Excellent written and verbal communication skills
• Proficient in MS Office applications, especially in MS excel