Clinical Trials Regulatory Submission Sr. Associate

Buenos Aires
Permanente
Tiempo completo

Hace 3 días

Career Category ClinicalJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Clinical Trials Regulatory Submission Sr. AssociateWhat you will doLet’s do this. Let’s change the world. In this vital role you will be responsible for performing Regulatory submissions in Argentina to ANMAT/ CCIS, compiling submission dossier, execution of all regulatory activities for clinical trial projects and programs, according to local regulations and Amgen’s policy.This position interacts directly with Functional Service Providers for Ethics Committee Services, Clinical Project Management (Local Trial Managers), Global Study Operations, International Regulatory Team, CMC Global Product Leads, Pharmacovigilance, Clinical Supply Chain and vendors acting as Importer of Record.

Performs efficiently end-to-end Clinical Trials Regulatory submissions in country for new and ongoing project(s) or programs, including and not limited to initial applications to ANMAT and CCIS, clinical protocol amendments, ICF amendments, quality (CMC) amendments, study periodic reporting, until the project is officially closed.
Submits, with the input of importer of record, study specific import licenses extensions until approvals.
Communicates overall regulatory status to internal teams and service providers.
Attends to project meetings with cross functional department leads to provide regulatory timelines and requirements for regulatory submissions and approvals.
Collaborates with internal team members to establish timelines and clarify regulatory requirements
Maintains clinical trial regulatory requirements' database, including regular updates to checklists.
Maintains local public registry in Argentina (ReNIS database) with input of Local Trial Managers.
Facilitates communication with the regional or local study team (e.g. Start-up Associates, Project Managers, Regulatory Affairs, Vendors, and Contracts Department) during the total duration of study, closely monitoring to ensure regulatory milestones are met.
Escalates issues to leadership, including plans for addressing/mitigating risks/gaps.

What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The professional we seek is a professional with these qualifications.Basic Qualifications:Master’s degreeORBachelor’s degree and 5 years of Clinical Trials experiencePreferred Qualifications:

Minimum 3 years of regulatory submissions and/or study start-up experience is required with strong technical knowledge performing Clinical Trial Applications in Argentina (ANMAT, CCIS)
Excellent written and verbal communication skills in English
Experience and/or technical knowledge in Import License extensions is a strong plus.
Ability to plan, develop, and manage timelines, including keeping them up to date.
Comfortable managing multiple projects and priorities at the same time.
Skilled at building and maintaining positive relationships with health authorities, colleagues, managers, and service providers.
Able to work independently and asynchronously across time zones in a collaborative, matrixed team environment — this is key!

What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation..

Amgen

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