Nonclinical Scientific Writer Fixed-term (2 years)

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

This position is in the Nonclinical Submission & Documentation Management (NDSM) team which is under the Enabling Sciences chapter. 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 Scientic 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 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.

• You have an openness and curiosity towards leveraging writing with automation technologies to enhance efficiency and quality.

Please note that this is a fixed-term position for the duration of 2 years.

In exchange we provide you with:

• Development opportunities: Roche is rich in learning resources. We provide constant development opportunities free language courses & training the possibility of international assignments internal position changes and the chance to shape your own career.

• Excellent benefits & flexibility: competitive salary and cafeteria package annual bonus Private Medical Services Employee Assistance Program All You Can Move Sportpass coaching / mentoring opportunity buddy program team buildings holiday party. We also ensure flexibility to help you find your balance: home office is a common practice (2 office days/week and we provide fully remote working conditions within Hungary).

• A global inclusive community where we learn from each other. At Roche we cooperate debate make decisions celebrate successes and have fun as a team. Our leadership is very focused on people creating a strong inclusive culture so you always have the chance to share your opinion.

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A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.