Clincal development center
méxico
are you passionate about clinical trial management and regulatory excellence do you thrive in an unordinary and dynamic environment where collaboration and innovation drive success if you have a strong background in clinical development and are ready to lead the way in ensuring seamless trial start-up activities we want to hear from you read on and apply today.
your new role
as a start up manager you will oversee clinical trial regulatory activities ensuring alignment with project goals and timelines. Your responsibilities will include:
ensure adherence to local and international regulatory requirements and good clinical practice (gcp) guidelines. Act as the escalation point for regulatory and start-up challenges driving resolution and ensuring continuity of trial activities.
provide strategic oversight and guidance to the regulatory start-up team fostering a culture of accountability collaboration and operational excellence. Coordinate cross-functional teams to facilitate trial approval and act as the primary point of contact for internal and external stakeholders during the regulatory phase.
develop and manage trial regulatory timelines identifying potential delays and implementing corrective actions to keep projects on track.
contribute to site activation processes ensuring timely ethics submissions and site readiness activities.
initiate and implement changes aimed at continuous improvement of clinical trial start-up processes and practices.
lead the regulatory and start-up strategy for clinical trials ensuring alignment with global standards and local requirements to enable timely and successful study execution. Optimise and centralise clinical trial supporting processes at the clinical development centre (cdc) level.
ensure team development and performance through coaching feedback and alignment with organizational goals.
your new department
as part of international operations you will join our largest operational unit. Covering 194 countries and 95% of the worlds population more than * of us work passionately to serve 35 million patients each day. With a promise to outperform the competition we continue to be the growth driver for novo nordisk and to improve health at scale across the globe.
you will be part of the clinical development centre (cdc) for the mexico affiliate a hub of excellence for clinical trial execution. Our department is responsible for overseeing all clinical development activities from initial planning to authority submission. We provide resources and expertise in biostatistics clinical reporting data management and clinical pharmacology to support development projects.
your skills and qualifications
we are looking for a candidate who possesses:
bachelors degree in life sciences pharmacy or a related field. Advanced degree (e.g. Masters or phd) is preferred.
minimum 6 years of experience in clinical trial management or clinical development with a focus on regulatory activities.
extensive experience managing regulatory processes with cofepris including submissions regulatory requirements approvals clinical trial processes and direct interactions with regulatory authorities.
minimum 3 years of experience as team leader managing a team within the regulatory department.
fluent english
working at novo nordisk
every day we seek the solutions that defeat serious chronic diseases. To do this we approach our work with an unconventional spirit a rare determination and a constant curiosity. For over 100 years this unordinary mindset has seen us build a company unlike any other. One where a collective passion for our purpose mutual respect and a willingness to go beyond what we know delivers extraordinary results.
what we offer
there is of course more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us while our benefits are designed with your career and life stage in mind.
more information
for more information facebook instagram xlinkedinand youtube. To complete your application click on apply now attach your cv and follow the instructions.
deadline
please apply before
november 27th *
novo nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
we commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
were not your typical healthcare a modern world of quick fixes we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science make healthcare more accessible and treat prevent and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real lasting change in health.
required experience:
manager