Title - Technical Writer - Pharmaceutical experience, Multi Lingual
Location - USA--Puerto Rico
Duration - 3 Months (March to June)
The CMC Author will be able to compare market dossiers in Spanish with site documents in either Spanish or English, and providing a difference review in English. They will be able to identify which documents are required from the site to perform the comparative analysis for specific sections of the market’s dossier.
Required Qualifications • Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Flexibility in responding to changing priorities or dealing with unexpected events.
• Capability to handle multiple priorities and balance work to achieve business goals.
• Effective leadership, communication, and interpersonal skills.
• Ability to prioritize tasks to meet deadlines and work with team when help is needed.
• Ability to identify problems and work with team to formulate a potential course of action
•Experience in the execution of Comparative (gap) analysis of registered CMC information (ICH CTD Module 3 or equivalent) against current manufacturing/packaging /testing sites documentation.
•Experience in the preparation and execution of Remediation plans as agreed with clients, such as the authoring of new or revised CTD sections.