Medical Records Director jobs in Boston, MA

• Providing strategic medical and scientific knowledge and supporting design, initiation, execution, completion, interpretation and reporting of clinical studies 

• Accountability for medical and ethical components of studies including patient safety on study level in compliance with Good Clinical Practice (GCP) and regulatory requirements 

• Delivery of the clinical and scientific components of all relevant study documents (e.g. Protocol, Statistical Analysis Plan, Informed Consent Form)  

• Accountability for ensuring safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting 

• Depending on experience, you may work as a GCH delegate across several studies and can be the clinical representative on indication Global Product Team and other sub-teams 

Essential for the role 

• Medical (M.D.) degree in relevant area  

• Good general medical knowledge in one of our core therapy areas in cardiology, nephrology, liver disease, diabetes, obesity or metabolic diseases,(by specialty training or specific research experience). 

• Special interest in diabetes, obesity and metabolic disease 

• Minimum 3 years pharmaceutical industry experience in clinical research  

• Experience of regulatory submissions 

• Excellent English, both spoken and written 

• Willing to be office based at our AstraZeneca R&D site in Boston 

With your excellent interpersonal, communication, and collaboration skills you have the ability to operate effectively across boundaries in a global matrix research environment to influence both internal and external stakeholders. 

Desirable for the role  

• Demonstrated 3 years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results 

• Clinical expertise in one of our core therapy areas, particularly in diabetes, obesity and metabolic disease 

• Good understanding of clinical trials methodology, biostatistics, global regulatory environment and pharmacovigilance 

• An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development 

• An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements 

So, what’s next? 

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you! 

Welcome with your application (CV and Cover letter) as soon as possible. 

Where can I find out more? 

CVRM at AstraZeneca: https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html 

Our commitment to advancing CVRM treatment: https://www.youtube.com/watch?v=pfTEz00kx4I 

Life at AstraZeneca : https://careers.astrazeneca.com/inclusion-diversity 

Why AstraZeneca? 

AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. There’s no better place to see what science can do.