...a highly motivated Medical Writer or Junior Medical Writer 60% (M/F) to strengthen our Development Department.
Prepare clinical and regulatory documents, e.g., clinical study protocols, clinical study reports, CTD documents, Health Authority Briefing Books and responses to requests for supplementary information, PIP submissions and modifications, according to applicable guidelines and Basilea project needs and timelines
Manage senior project team and corporate review and approval of clinical, regulatory and related documents, including leading Protocol Review Committee meetings when required according to agreed project timelines
Maintain relevant Medical Writing SOPs, templates, and other elements of the documentation infrastructure
Support the management of several outsourced medical writing tasks, including maintenance of relationships with external medical writing providers
Support the preparation of nonclinical and Medical Affairs scientific documentation according to applicable guidelines and Basilea project needs, if required
Mother-tongue English or equivalent
MD or PhD/MSc in life sciences, or other relevant qualifications and industry experience, or for the entry-level position, graduate or post-graduate qualifications in life sciences
Minimum 5 years of relevant work experience in the pharmaceutical industry or for the entry-level position, substantial professional or post-graduate writing experience with relevant work experience in the pharmaceutical industry an additional advantage
Previous experience with regulatory submissions in the EU and/or USA
Experience in oncology or anti-infectives an additional advantage
Excellent written and oral communication skills
Ability to work both independently and collaboratively in a team environment with a high level of integrity and managing multiple parallel projects
