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At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
The Position
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 fearless in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.
In Roche’s Pharmaceutical Research and Early Development organisation (pRED), we make transformative medicines for patients in order to tackle some of the world’s toughest unmet healthcare needs. At pRED, we are united by our mission to transform science into medicines. Together, we create a culture defined by curiosity, responsibility and humility, where our talented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.
pRED’s Pharmaceutical Sciences (PS) group enables discovery and development of safe and effective therapeutics at optimal doses in relevant populations with a vision to power translation, continuously improve the accuracy of our predictions and accelerate the development of tomorrow's medicines. PS supports discovery and development across the whole value chain from target assessment to on-market.
This position is in the Nonclinical Submission & Documentation Management (NDSM) team, which is under the Enabling Sciences chapter within PS. The NDSM team collaborates closely with scientific and regulatory stakeholders across Roche Pharma to prepare compliant nonclinical regulatory documentation and ensure successful submissions to the Health Authorities (HAs).
The Opportunity
As a nonclinical scientific writer, you are managing the submission of Roche-authored nonclinical documents to regulatory agencies in support of applications such as INDs, CTAs, NDAs, MAAs, and BLAs. With your scientific writing capabilities, you ensure that the documents are clearly written, accurate and consistent, adhere to Roche and ICH standards, and are reviewed and approved by the appropriate functional groups.
In this position, you will:
* Manage the preparation, review, and submission of nonclinical summary documents for both early development and marketing applications
* Work with regulatory and scientific functions across Roche to ensure comprehensive and accurate nonclinical dossiers are being submitted to HAs
* Work closely with Nonclinical Project Leaders and Scientists in composing regulatory submission documents, study reports and other research-related documents
* Develop and maintain processes, tools, and guidelines enabling high-quality document production
* Represent the nonclinical team in global regulatory initiatives and projects focused on process and technology development
Who You Are
* You hold a university degree in a life science.
* You have several years of working experience in scientific writing and editing in a regulatory environment, preferably in the nonclinical domain.
* You have an excellent command of writing and editing software, with an interest in exploring and integrating new tools and technologies.
* You build a culture of trust around you and are comfortable working with a wide array of stakeholders.
* You are obsessed with meeting customer needs and thus, high-quality documentation.
* You take ownership of your work and are proactive in taking action to resolve issues
Unwavering focus, collaborative teamwork and exceptional delivery are key behaviours that drive our mission of doing now what patients need next. Together, we can be transformative.
If you are passionate about contributing to a committed team and have the dedication to partnership and innovation, Roche is the place for you! Every role at Roche plays a part in making a difference in patients’ lives.
Apply now and join us in making an impact!
Who we are
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Science, and Engineering
* Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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