Description

• Provide operational support within the team to execute designated tasks associated with submission.
• coordination activities for assigned products and/or at required dossier execution process workflow as
• Accountable for delivering designated submissions with quality and timely as per applicable policy, SOP/Work.
• Instructions, guidelines, or service level agreement.
• Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Escalate, inform, and/or resolve any issues that may impact timeline, quality, or compliance of submissions.
• Commit to completing required on-the-job training courses to ensure training compliance is preserved.
• Promotes the use of Document Management and Archival systems and standard document authoring and publishing processes, partnering with supplier groups as necessary to produce timely delivery of
• submission/archive ready components.
• Commit to completing required on-the-job training courses and Curriculum to ensure compliance is preserved.
• Execute regional specific tasks to support on time project delivery.
• Able to operate at pace with agile decision-making skills. Uses evidence and applies judgment to balance pace, rigour, and risk.
• Command necessary knowledge and skills of regional submissions and ensure regulatory or business requirements are fulfilled.

Requirements

• Qualification: Bachelor’s / Master’s degree in pharma or lifesciences.

Skills

• Experience in managing in a matrix environment
• Proven experience in decision making and tight deadlines
• Customer service experience
• Technically adept using IT systems and software
• General understanding of healthcare regulatory environment
• Fast learner with proven ability to adapt to changing demands

• Interested candidates can share their updated CVs to milanashree.r@clinchoice.com