Medical Writer - in Ophthalmology

Job content

The PositionIn 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 ourtalented people are empowered and inspired to bring forward extraordinary life-changing innovation at speed.This position is within the Ophthalmology team, part of the Immunology, Infectious diseases, and Ophthalmology (I2O) Discovery and Translational Area (DTA), which is continuously growing and innovating. We partner and collaborate with leading scientific institutions worldwide to tackle grand challenges by assembling, funding, and leading interdisciplinary teams of experts to work on highly ambitious and complex scientific questions.The PositionThe Ophthalmology department is looking for a skilled and experienced Medical Writer with expertise in scientific communications to support the growing team and contribute to the continuity of a successful pipeline. The Medical Writer will join a dynamic and active group and be involved in key milestones of clinical development, including planning, execution and completion of Clinical Trials. The role requires strong teamwork and collaboration skills, as well as stakeholder management.Your main responsibilities are:

• Author and prepare clinical study documents to support clinical trials and regulatory submissions, in accordance with Roche internal and international regulations and guidelines, including but not limited to clinical study protocols, protocol amendments and informed consent forms
• Lead or assist in the authoring of other scientific documents such as scientific manuscripts, abstracts, posters and publications in the ophthalmology area
• Support the teams in the development of a scientific communication strategy aligned with the milestones of the program
• Ensure that key messages and critical issues are accurately and consistently presented across documents, with attention to detail for scientific accuracy, layout and design
• Perform quality control review of other study documents prepared for clinical trials/ regulatory submission
• Prepare detailed timelines of writing activities for assigned documents and validate dates with all impacted team members
• Ensure coverage of writing activities in accordance with the project objectives and project-specific milestone dates
• Participate in Clinical Team Meetings and collaborate closely with Clinical Science
• Collaborate with cross-functional individuals in support of project deliverables
• Collaborate with other Medical Writers across the company to improve and harmonize templates and processes
• Participate in/ lead initiatives involving medical writing/ scientific communication expertise.
• Ensure compliance with Roche publication policies and processes and with external guidelines on good publication practices

Who you are:Essential:

• At least 2 years scientific/ medical writing experience in the pharmaceutical industry
• Graduate degree in a life science discipline
• Excellent scientific/ medical writing skills
• Effective verbal and written communicator
• Fluent in English, both written and spoken
• Good knowledge and understanding of ICH-GCP
• Author of scientific publications
• Expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowledge and experience with other team members
• Ability to coordinate matrix organizations and demonstrated ability to influence changes across diverse teams
• Ability to set priorities, deal with ambiguity and ability to be independent, multi-tasked, results oriented with a hands-on attitude in an fast-paced and energetic environment

Desirable:

• Advanced degree (Ph.D., Pharm.D. or MD) in a life science discipline is preferred
• Experience with IDMdirect and Veeva Vault RIM (integrated document management and submission platforms)
• Prior experience in scientific communications (publications or medical communication) including development of strategies/ plans
• Previous experience in Ophthalmology

Our commitmentRoche commits to recognizing talent and aptitude. We prioritize encouraging and supporting our employees on their personal journeys by providing a safe, creative space to help them reflect, make decisions and grow in their career.We are confident that we find the most innovative solutions by gaining different perspectives, asking and answering hard questions, and challenging the status quo. Roche embraces diversity and equal opportunity in a serious yet enthusiastic way; we are devoted to building a team that represents a range of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be..Who we areAt Roche, more than 100,000 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.Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.Roche is an Equal Opportunity Employer.