My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.
Due to this growth my client is looking for a Medical/Scientific Writer.
The position will report to the Head of Clinical Development Department.
YOUR RESPONSIBILITIES :
Ø Prepares and finalises clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, summary documents, RMPs (initial and updates), regulatory responses, and briefing documents. Documents must be of high quality in terms of scientific content, as well as organisation per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency;
Ø Leads cross-functional document planning and review meetings;
Ø Leads in a team environment with greater independence for longer-term activities, and takes a lead role on assigned projects concerning timing, scheduling, and tracking;
Ø Indirectly or directly leads or sets objectives for others on team projects and tasks; e.g., able to lead process working groups;
Ø The primary point of contact for Clinical Development Team for medical writing activities;
Ø Responsible for functional planning and metrics database updates for assigned program.
YOUR PROFILE :
Ø PhD or Master in elated Pharmaceutical Science with minimum 3 years experience of relevant regulatory medical writing
Ø Ability to function (and potentially lead) in a team environment;
Ø Demonstrates learning agility ;
Ø Builds solid and productive relationships with cross-functional team members;
Ø Strong project management skills
Ø Strong leadership skills
Ø Fluent in English and French.