/ Hiring

Non-interventional Program (NIP) Coordinator

Who We Are

At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.

The Position

Summary of Position:

The non-interventionalprogram (NIP) Coordinator is the specific point of contact for requestsregarding NIPs.  The NIP Coordinatorensures that all NIPs conducted by Genentech are approved, tracked, andconducted in accordance with relevant regulations and company internalprocesses and procedures.

 

Job Duties/Responsibilities:

• Liaison with the BusinessUnits to ensure a proactive review and assessment of all proposed NIPs.
• Provide support to scopestaff handling NIPs by answering questions or providing advice on good NIPpractices as defined in laws & regulations, codes and internal guidelines& SOPs
• Ensure timely involvementof line management in case of violation of good NIP practices
• Create and maintaintraining for good NIP practices, regulations, codes and internal guidelines& SOPs
• Ensure scope staffawareness of ongoing changes to regulatory or local requirements, and new proceduresand policies on NIPs. Co-ordinate in-house and external provider training byliaising with other departments, external trainers, or running courses,including functional orientation/induction program for new employees
• Identify the need forcreating additional or updating existing SOPs or processes/working guidelineson good NIP practices
• Responsible for tracking of NIPs under their scope of responsibilityinto NIP database(s)
• Ensure each NIP has a program outline which details the nature of the program and safety data collection and reporting processes
• Proactively reportsconcerns/issues to the NIP Coordinator Lead toensure compliance with safety SAE and non-serious AE reporting requirements are met
• Ensure a quality control and reconciliation process is in place for on-goingNIPs and conduct a NIP risk assessment at least once a year as per globalSOP(s)
• Liaise with other NIPcoordinators and be a proactive member of the global NIP network (identify newNIP requirements, develop preventive and corrective measures against NIP risks,maintain and promote good NIP practices across GPS and affiliates)

Who You Are

Competencies Identified forSuccess:

• Works effectively as a teammember and promotes collaboration
• Demonstrates initiative andaccountability
• Strong organizational andproject management skills
• Confident decision maker
• Networking, influencing,and interpersonal skills
• Excellentcommunication skills, both written and verbal

 

Education, Experience, andOther Requirements:

• BachelorDegree, preferably in a health or life science related area
• Minimum3 years of experience in the pharmaceutical industry, preferably in a drugsafety department
• Experienceworking in a matrix organization

The next step is yours. To apply today, click on the "Apply online" button below.

Genentech is an Equal Opportunity Employer.