• Job Description

  Req#: 202406-114785

  Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

  The Position

  A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.

  The Opportunity

  The Clinical Development Lead is an integral member of the Roche Diagnostics Solutions (RDS), Clinical Development Medical Writing team and whose primary focus is to develop clinical study documentation such as protocols, clinical study reports, investigator’s brochures, validation/performance plans and reports, etc. The Clinical Development Lead is responsible for the planning and implementation of Clinical Development activities for assigned products.
  

  RDS’ Scientific focus areas include Infectious Diseases, Oncology, and Cardiovascular and Metabolic Diseases. Technological focus areas include PCR, sequencing, immunohistochemistry, and immunological testing among others.

  • You will be accountable for the timely development and delivery of high-quality documents; you will oversee and manage the entire document lifecycle; serve as the primary contact for assigned work and ensure adherence with relevant Roche procedures, regulatory requirements, quality control systems/procedures, and journal requirements for scientific publications

  • You will conduct comprehensive literature reviews, cohesively collate relevant clinical and scientific information from different sources, and create new scientific content with minimal guidance/direction

  • You will actively participate in project teams/extended project teams to support clinical study design and execution activities, including critical review of study results, protocol and report generation to support new product development

  • You will provide medical/scientific input and assist with the preparation of regulatory submissions as well as responses to reviewers from regulatory agencies; you will maintain clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation

  • You will support colleagues with less experience and help them develop skills/expertise; you will foster an engaged work environment that strives for continuous improvement, professional development, living the Roche cultural beliefs, and exhibiting skills of agility, effective decision-making, adaptability to change, and influencing without authority.

  • You will be responsible for proactive timeline management, project and process management, cross-functional meeting coordination, strong, effective communication, active participation in team meetings, demonstrating attention to detail, and simultaneously leading several projects to completion.

  • You have the ability to travel occasionally domestically and internationally to select conferences and/or internal meetings

  This position can be onsite at one of our US Roche Sites (Pleasanton, CA; Tucson, AZ, Indianapolis, IN) or remote.

  No relocation benefits will be provided for this position.

  Who You Are:

  (Required)

  • You hold a PhD or doctoral degree in life sciences with relevant experience in the Healthcare industry and/or academic institutions

  • You have 5+ years experience in academia and/or the healthcare industry (diagnostics, medical device and/or pharmaceutical industry) with a demonstrated level of proficiency with common word processing tools (i.e. Microsoft Suite)

  • You have proven writing experience in an academic and/or life sciences industry setting, including First-Author publication(s) in a peer-reviewed journal(s)

  • You have strong interpersonal skills, verbal communication and influencing skills; you can influence without authority and excellent organizational, stakeholder management, project and process management skills; and the ability to drive several high-impact projects simultaneously. You have experience building and cultivating relationships with key partners and stakeholders, both internally and externally

  Preferred:

  • You have a proven track record of leading and performing in a fast-paced, matrix environment; ability to work independently and influencing others with strategic decisions

  • You have experience understanding basic statistical techniques

  • You have a strong understanding of clinical development, including clinical study design

  • You have the ability to partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity.

  Relocation benefits are not available for this job position.
  

  The expected salary range for this position based on the primary location Tucson, AZ is $87,300 - $162,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

  Benefits

  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.

  Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

  If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants .

• About the company

  606018 F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics.

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