Medical Writer

Job description

·  Job facts

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 fearless in both decision and action. We believe that good business means a better world.

We are looking for a Medical Writer to join our Basel based pRED (Pharma Research and Early Development) Oncology Early Development team at the Roche Innovation Center in Basel. In this role, you will interact closely with a team of clinical scientists and specialists working on novel classes of cancer therapy agents. You will edit and proofread clinical documents, coordinate processes as well as support Clinical Expert /Study Management teams. In addition, you will:

· 
Support the development of high-quality clinical documents e.g. study protocols, amendment documents, informed consent forms, subject information leaflets etc.

· 
Be accountable for planning, creation and co-ordination of timelines for the production and review of clinical protocol-related documents ensuring alignment with overall project timelines.

· 
Co-ordinate the clinical protocol-related documents draft and review process including generation of draft document from content provided by contributing authors; collection, adjudication, and incorporation of comments from a matrix team, cross-functional and functional reviewers; and resolution of issues/errors/inconsistencies with team members.

· 
Edit and/or proof-read pRED clinical protocols and related documents in alignment with local and global guidelines.

· 
Support selection and management of appropriate templates within the documentation system.

· 
Be responsible to ensure documents are published and approved by the accountable signatory.

· 
Support protocol development process improvement initiatives

· 
Participate as needed as a member or ad-hoc participant of key functional/cross-functional teams (i.e., project team, clinical team, study management team) to ensure appropriate documentation guidance and support.

· 
Collaborate with Regulatory Clinical Documentation Group to ensure consistency of submission documentation.

To be successful in this position, you have:

· 
Bachelor's degree in life sciences or equivalent.

· 
Advanced degree in life sciences (i.e., MS, PhD) or other relevant field is preferred.

· 
3-5 years of experience in writing clinical documents or regulatory reports.

· 
Demonstrated high-quality scientific writing style in the English language.

· 
Experience in early stage drug development is preferred.

· 
Thorough understanding of multidisciplinary functions involved in early stage Drug Development Process is essential (e.g., Clinical Operations, Biostatistics, Regulatory, etc.).

· 
Experience as a coordinating author and with providing editing and prof-reading support for clinical documents for various therapeutic areas and global programs is desirable. Experience with working on clinical documents in the field of oncology is a plus.

· 
Understanding of Federal Regulations and International standards as they pertain to reporting of clinical trials.

· 
Good interpersonal and verbal communication skills

· 
Strong team player

· 
Experience and demonstrated matrix collaboration skills.

· 
Ability to motivate and work effectively with global matrix teams

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.