Submission Delivery Specialist,Assembly

Job Purpose:

Assemble, link and publish submission packages that meet Regulatory Authority technical standards and GSK requirements and schedules.

Key Responsibilities:

Delivery of submission packages to agreed schedule and technical specification
Advise and assist authors with the preparation of submission content and use of GSK document management systems and procedures
Maintain knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format
Participate in the creation and implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality.

Knowledge/ Education / Previous Experience Required:

Bachelor’s degree in biological or healthcare science.
Master’s degree in related studies is a plus.
1-2 years of working experience.
Good experience within Regulatory Affairs in the Drug development environment.
Good written and verbal communication in the English language is a must.
Basic computer/Microsoft office knowledge.
Good knowledge / experience with the use of complex IT tools is preferred.
Good level of French language is a plus.
Service orientation professional and customer-focused.
Excellent organizational skills and attention to detail.
High level of commitment to the deadlines and to the level of quality, dealing in a professional way under pressure.

Pharma Road