Medical Writer - Translational Medicine Ophthalmology
At Roche, we believe it is urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and we are ambitious in both decision and action. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Roche Pharma Research and Early Development (pRED) Ophthalmology is in constant evolution. Our current focus are retinal diseases, but we are constantly looking into novel opportunities such as Dry Eye Disease or Glaucoma.
The Position The Ophthalmology early development group is looking for a skilled and experienced Medical Writer to support the growing team and contribute to the continuity of a successful pipeline. The Medical Writer will join a dynamic and active group and be involved in key milestones of clinical development, including planning, execution and completion of Clinical Trials. The role requires strong team work and collaboration skills, as well as stakeholder management.
Key deliverables & accountabilities ? Author and prepare clinical study and regulatory documents to support clinical trials and regulatory submissions, in accordance with Roche internal and international regulations and guidelines, including but not limited to clinical study protocols, protocol amendments, informed consent forms. ? You may also lead or assist in the authoring of other scientific documents such as abstracts and publications. ? Ensure that key messages and critical issues are accurately and consistently presented across documents, with attention to detail for scientific accuracy, layout and design. ? Perform quality control review of documents or parts of documents prepared by other staff. ? Prepare detailed timelines of writing activities for assigned documents and validate dates with all impacted team members. ? Ensure coverage of writing activities in accordance with the project objectives and project-specific milestone dates. ? Participate in Clinical Team Meetings and collaborate closely with Clinical Science. ? Manage multidisciplinary meetings and contributions. ? Collaborate with cross-functional individuals in support of project deliverables. Collaborate with other Medical Writers to improve and harmonize templates. ? Might manage outsourcing providers.
In addition to the responsibilities as a Medical Writer, the candidate might take over Clinical Scientist responsibilities like: ? Collaboration with contract specialists for the compliant engagement of consultants (healthcare providers) ? Assisting in all areas of project and study planning, evaluation and documentation
Essential: ? At least 2 years scientific / medical writing experience in the pharmaceutical industry ? Graduate degree in a life science discipline ? Excellent scientific / medical writing skills ? Excellent communication skills ? Excellent written and spoken English ? Good knowledge and understanding of ICH-GCP ? Expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowledge and experience with other team members Desirable: ? Advanced degree (Ph.D., Pharm.D. or MD) in a life science discipline is preferred. ? Previous experience in Ophthalmology
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Research & Development, Research & Development > Clinical Development