Associate Director, Principal Medical Writer
A global biopharmaceutical company is looking for a talented and creative Principal Medical Writer, Associate Director to join their team in Geneva. This organisation is focused on finding solutions for serious unmet medical needs, this role is essential in communicating this discovery with the world.
- Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.
- Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
- Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
- Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
- Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality. Lead or participate in cross-functional process improvement initiatives.
- Mentor more junior medical writing staff.
Skills and Requirements
- Bachelor's degree in a life science discipline, with master's degree in life science discipline preferred
- At least 6 years writing experience in the biopharmaceutical/CRO industry required.
- Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
- Proficiency in organizing and communicating clinical information necessary
- Strong communications, organizational, time management, and project management skills are required.
- Proficient in MS Word. and experience with template systems
- Experience with an electronic document management system and use of templates preferred.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Oliver Jones on 02038541077 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.