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
Bachelors degree in biological or healthcare science.
Masters 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.
Contact Information
You may apply for this position online by selecting the Apply now button.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in
respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Apply for here
