Clinical Development Lead (Medical & Scientific Writing)

Roche; Sant Cugat del Vallès; Presencial; EUR 105.000 - 140.000; Jornada completa

Descripción de la vacante

Roche Diagnostics Solutions, an industry leader in clinical diagnostics, seeks a Clinical Development Lead within the CEI team to drive documentation across clinical studies and regulatory submissions for IVD development.

You will collaborate with SMEs from CDMA and other functions to design studies, prepare protocols and reports, and ensure timely, high-quality deliverables with robust scientific integrity.

Formación

• Solid experience in scientific research and proven scientific writing in clinical or regulatory documents.
• Experience with regulatory writing for IVD/medical devices preferred.
• Understanding of laboratory techniques or statistics is a plus.

Responsabilidades

• Oversees and manages the entire document lifecycle for clinical study documents and regulatory submissions.
• Co-develops clinically sound studies with SMEs from CDMA and other functions.
• Participates in project teams to support study design, protocol and report generation, and results review.
• Analyzes product portfolio to support compliance with IVD-Regulation through documentation.
• Collaborates with Medical Affairs-Scientific Communications for manuscripts and boards.
• Interfaces with CEI team to share best practices and support process improvements.
• Maintains timelines and coordinates cross-functional meetings while leading multiple projects.
• Mentors junior CEI team members and contributes to a culture of continuous improvement.

Conocimientos

Scientific writing

Regulatory understanding

Cross-functional collaboration

Educación

PhD/MD/PharmD or advanced life sciences degree

Descripción del empleo

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

At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.

We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster.

Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the Clinical Development chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life.

The Opportunity

The Clinical Development Lead is an integral member of the Clinical Development Clinical Evidence In-Vitro Diagnostics (CEI) team at Roche Diagnostic Solutions (RDS) whose primary focus includes providing documentation support for a multitude of clinical study documents, including reports, protocols, clinical study reports, investigator brochures etc., and IVDR performance evaluation documents. The position will function as a strategic partner within Clinical Development to support clinical evidence generation and/or clinical study design of In Vitro Diagnostics (IVD) for registration with regulatory agencies.

• Oversees and manages the entire document lifecycle. Serves as primary contact for assigned work and ensures the timely delivery of high quality documents in accordance with relevant Roche procedures, regulatory requirements, quality control systems/procedures, and journal requirements for scientific publications.
• Co-develops scientifically sound clinical studies in conjunction with subject matter experts (SMEs) from CDMA and other functions to support new product development.
• Actively participates in project teams/extended project teams to support clinical study design and execution activities, including protocol and report generation, critical review of study results etc.
• Strategically supports clinical evidence generation by analyzing the product portfolio across a specific customer area and creating documentation to support compliance to IVD-Regulation.
• Conducts comprehensive literature reviews, cohesively collates relevant clinical and scientific information from different sources, and creates new scientific content with minimal guidance/direction.
• Partners with the Medical Affairs-Scientific Communications team to offer ad-hoc writing support for select manuscripts, posters, and advisory boards.
• Interfaces closely with other members of the CEI team to share best practices, transparently communicate project/customer area-related lessons learned, and support team management and process improvement activities (such as GSP/template updates, managing collaborative work tools, improving quality control, exploring automation opportunities, managing reference libraries etc).
• Responsible for proactive timeline management, project and process management, cross-functional meeting coordination, effective communication, building healthy relationships with team members, active participation in team meetings, demonstrating attention to detail, and simultaneously leading several projects to completion.
• Successfully completes all assigned curricula and on-the-job training modules.
• Acts as a mentor to less experienced members of the CEI team.
• Fosters an engaged work environment that strives for continuous improvement, professional development, living the Roche cultural beliefs, and exhibits skills of agility, effective decision-making, adaptability to change and influencing without authority.
• Maintains clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation.
• Provides medical/scientific input into and assists with the preparation of regulatory submissions. Provides responses to reviewers from regulatory agencies, as applicable.

Who are you

• You have a Doctoral or advanced degree (e.g., PhD, MD, PharmD etc.) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, or other related fields.
• You have solid experience in scientific research and proven scientific writing experience in an academic or industry setting with a variety of clinical or regulatory documents, including clinical study protocols and reports
• You have experience with regulatory writing for in vitro diagnostics or medical devices, including companion diagnostics (preferred).
• You have an understanding of laboratory techniques in one or more of the following areas: PCR, sequencing, serology, microbiology, clinical virology, immunohistochemistry, immunological assays (preferred).
• You have an understanding of basic statistical techniques (preferred).

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Burgess Hill. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 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.

Let's build a healthier future, together.

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.