Roche - Regulatory Content Strategist (Medical Writer) - Hybrid Role

The Position

Imagine working for an organisation that focuses on putting people at the heart of what they do. Where every single person within the organisation is aligned to one main motivating force, that at the centre of everything they do, and their number one priority; are patients. A place that gives every individual the autonomy and empowerment to make a difference, where you are not defined by a job title. Imagine waking up every morning feeling fulfilled, having purpose and meaning in your work.

Imagine you are at Roche.

We are a pioneer in pharmaceuticals, advancing science to help people live longer and healthier lives. For over 120 years we have created truly differentiated medicines for cancer, the immune system, infectious diseases, ophthalmology and diseases of the central nervous system.

We work from bench to bedside - researching new medicines, running global clinical trials, and collaborating with the NHS to try to ensure rapid uptake and delivery of our products and services.

Our drive, every day, is to ensure our medicines reach those who need them as soon as possible.

None of this would be possible without our extraordinary employees; our people make our business. We offer inspirational opportunities for employees that are as unique as they are. We have created an inclusive, respectful work environment where people can be authentic and truly invested in their work, a place to belong.

Regulatory Content Strategist (Medical Writer)

We are seeking experienced Regulatory Content Strategists (RCS) to join our passionate Regulatory team. Depending on the candidate we have three levels of RCS: Associate, Senior and Principal.

As the Regulatory Content Strategist you will lead cross-functional teams in content preparation for submission to regulatory authorities; partners closely with key stakeholders, applies critical thinking, scientific writing, data interpretation, and knowledge of regulatory content life-cycle.

Responsibilities and Accountabilities:

• Assists with the preparation of regulatory content in accordance with applicable regulatory guidelines/Roche standards/SOPs
• Plans content and creates timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
• Reviews documents for organization, clarity, scientific standards, and consistency of content, data, and messaging. Resolves issues with cross-functional contributors. Ensures compliance with regulatory requirements
• Manages the review and approval process
• Ensures that documents are published in collaboration with Regulatory Operations
• Is a key strategic participant in functional and cross functional teams
• Actively contributes to best practices and continuous improvement initiatives and projects
• Maintains up-to-date knowledge of key regulatory, scientific, and medical topics relevant to drug development, assigned products, and disease/therapeutic areas

Experience, knowledge and skills:

• Bachelor’s degree or equivalent. Advanced degree in life sciences or related field, or equivalent experience, preferred
• Demonstrated ability to produce clear, high-quality scientific writing in the English language
• Ability to independently analyze and synthesize data and non-clinical and clinical concepts from a broad range of disciplines
• Project management skills: consistently achieves multiple tasks and goals on-time
• Strong interpersonal, and verbal and written communication skills
• Ability to work effectively on cross-functional, geographically diverse teams, establishes strong collaborative relationships
• Thinks through problems clearly and logically
• Adapts to changing conditions

At Roche, it is more than just a job. It’s a responsibility. A big one. If you really know yourself and want to be part of our international family, dedicated to making a real impact on the world around us, the next step is yours, apply above and join us on our transformational journey.

Good luck with your application! To Apply, please click here

Who we are

At 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.

Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions.

Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK. Roche is committed to creating a diverse & inclusive environment. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.