Permanent Principal Medical Writer (M/F) - Permanent - Switzerland
Our client is an international company with a strong pipeline that is currently looking for a permanent Principal Medical Writer(M/F) to join the team located in Switzerland. You will be in charge of preparing the clinical documents. For more information, please contact Louise Beka on +44 207 255 66 65 or louise.beka@secpharma.com
You will be involved in study and clinical team meetings and support the team members with regards to document preparation.
Additional responsibilities will include:
-In collaboration with other relevant line functions, prepare, develop and give directions for clinical and regulatory documents and responses to health authorities
-Review other writers' documents according to the specific medical writing requirements
-Prepare internal guidelines for document preparation and templates for clinical documents in compliance with specific guidelines
-Supervise and review all the medical writing projects that are outsourced
- Manage teams and medical writing projects
- Review work, coach and train the other writers
Skills/Knowledge Required:
-BA/BSc/MSc/PhD in sciences or equivalent
-Scientific or medical background
-Minimum 8 years' experience as a Medical writer or Scientific Writer in a pharmaceutical/biotech/biopharma/CRO company
-Proven experience with the CTD modules (5; 2.5; 2.7.3 and 2.7.4)
-Previous experience in regulatory writing and submissions
-Previous experience as a lead of at least 1 submission (i.e., accountable for the preparation of all summary documents)
-Demonstrated experience with the use of Word and electronic templates
-Excellent grammatical and communication skills (written and oral)
-Knowledge of ICH and health authority guidelines
-Previous experience in preparing clinical documents, clinical study reports, integrated summaries of efficacy and safety, registration dossiers, and responses to health authorities
If you are interested in this position, please send your application to Louise Beka (louise.beka@secpharma.com ) or for more details please contact me on +44(0) 207 255 66 65
SEC Recruitment Limited is acting as an Employment Agency and/or Employment Business