Regulatory Documentation Scientist

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 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.

The Position

Here is a great opportunity to combine your scientific knowledge and writing skills in an important role with one of the world's leading healthcare companies.

Roche's Global Regulatory Documentation department prepares documents to meet the evolving needs of Health Authorities using our expertise in writing, science and regulatory requirements. As a valued member of the department, here are some responsibilities you will have whilst working with the global drug development teams:

·  Bring novel pharmaceutical products to patients worldwide through planning and preparing a broad range of regulatory documents. Our scope encompasses periodic safety reports, risk management plans, clinical study reports, and summaries of clinical data across studies, among many other document types
·  In addition to authoring individual documents, you may also be responsible for broader oversight and management of the regulatory documents for a molecule or project within the portfolio
·  Work closely with colleagues in safety science, biostatistics, clinical science, and regulatory affairs, among other functions, on projects across the drug development lifecycle and a range of therapeutic areas
·  You will also have the opportunity to contribute to best practices and continuous improvement activities and to take part in mentoring programs within Regulatory Documentation

Who we are

At Roche, 94,000 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.

Desired profile

Who You Are

You're someone who wants to influence your own development. You are looking for a company where you receive the opportunity to pursue your interests across functions and geographies. Working in a multi-cultural environment motivates you. As a fast learner you actively drive the quality of the requirements.

Qualifications:

·  You have a PhD, MS, or equivalent in a biomedical discipline or a qualification in pharmacy, nursing, or another healthcare discipline
·  Skilled communicator, comfortable working as part of cross-functional teams
·  Strong organizational skills necessary to deliver multiple documents on schedule
·  Previous medical writing experience and/or experience writing regulatory documents in the pharmaceutical/biotech industry
·  Knowledge of Good Clinical Practice and/or Pharmacovigilance guidelines will be an advantage

When completing your application, please attach a cover letter detailing how your experience and personal attributes make you suitable for this role.

If you are proud of contributing and feel you have the dedication to teamwork and innovation that we are seeking, then Roche is the organization for you. Every role at Roche plays a part in making a difference to patients' lives. If you want work in a passionate team, make your mark & improve lives, apply now.

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. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

If you have questions, please check our FAQs and videos on careers.roche.ch/faq.

·