Scientific Writer

Job description

·  Job facts

At Roche, we believe it's 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 confident in both decision and action. And we believe that good business means a better world.That is why we come to work every single day. We commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

The Nonclinical Reporting & Regulatory Submissions group in Pharma Research and Early Development (pRED) provides documentation support to about 250 nonclinical scientists worldwide. We prepare high-quality nonclinical regulatory documents for submission to health authorities. Nonclinical documentation activities range from formatting data for study reports to editing and leading nonclinical documentation management for global submissions. In the course of our activities, we engage with a variety of scientific and regulatory functions across Roche and are always on the lookout for synergies and efficiencies. We have a solid team approach to our work, as well as provide team members the opportunity to develop their own specializations and talents.

In this position you will:

•Lead nonclinical filing teams (NCFT) in the preparation of the nonclinical documentation for marketing applications
•Manage the preparation, review, and submission of nonclinical CTD summary documents as a member of regulatory affairs functional teams (RAFT)

•Work closely with Toxicology, Pharmacokinetics and Pharmacology Project Leaders and Study Directors in composing regulatory submission documents, study reports and other research-related documents
•Review the format, completeness, and language of scientific documents
•Provide journal publication editing support
•Proactively develop and improve internal processes and guidelines enabling high-quality document production
•Represent the nonclinical team in a variety of initiatives and process improvement projects

You have the following qualifications:

•University degree in a life science
•Experience in writing and editing in a regulatory environment
•Excellent command of writing and editing software (e.g., Microsoft Word, Adobe, EndNote). Additional technical skills are a strong plus
•Strong communication, collaboration, and project management skills

Are you ready to apply? We want someone who thinks beyond the job offered - someone who knows that this position can be a rare springboard to many other opportunities at Roche.

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

Roche is an equal opportunity employer.
Research & Development, Research & Development > Clinical Development

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.