Associate Medical Monitor, Medical Director, CNS, Americas (US, Canada, LATAM)
Location: Boston, Massachusetts, United States
Requisition Number: 4320
Position Title: Associate Medical Monitor, Medical Affairs
Who we are
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 2,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
What Medical Affairs does at Worldwide
Medical Affairs impacts every stage in the lifecycle of a clinical investigation. From Business Development to Regulatory Submissions, members of the MA team support the larger project team, and help establish the medical orientation that characterizes the philosophy here at Worldwide.
Activities include direct interactions and presentations with medical and operational personnel from pharmaceutical companies in the process of business development; protocol preparation and country specific feasibility assessments for proposed investigations that inform study design and operational metrics; training of investigative site staff and members of Worldwide project teams on medical or assessment methodology unique to a given study, and the medical monitoring of adherence to enrollment criteria for study candidates as well as medical management activities for patients during the course of the trial. A pharmacovigilance activity for adverse event analyses and reporting is an integral part of the service offering. Medical Affairs also partner with other functional groups within the Worldwide organization for the design and execution of "first in man" studies (CEDRA), the generation of statistical and clinical reports at study conclusion, and scientific/medical assistance in the preparation of regulatory submissions such as investigative new drug applications which permit the initiation of clinical testing.
What you will do
- As directed by Medical Affairs management or Therapeutic Medical Leads provide initial review, compilation and reporting of study data; Provide operational support to Medical Affairs function.
- Prepare meeting agendas, manages functional project review documentation, develop and manage study documents pertaining to Medical Affairs, take minutes for respective meetings; responsible for updating the functional documents repository.
- Assist Medical Affairs management with internal budget management, tracking and forecasting.
- Assist with verification of contracted services as directed by Medical Affairs function head or Therapeutic Medical Lead(s)
What you will bring to the role
- Excellent written and verbal communication skills, excellent spoken and written English skills
- Ability to work independently and as a team member; strong organizational skills
- Strong interpersonal skills in a fast-paced and rapidly changing environment
- Ability to exercise independent judgment with sensitivity to decisions requiring supervisory approval
- Ability to handle multiple tasks, including rapid response in generating new documents, forms and tools
- Advanced skills in MS Office applications including Microsoft Word, Access, Excel, PowerPoint and Publisher; knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science and minimum 5 years of industry experience or medical degree (M.D.) with a minimum of 1 year of industry experience
- Ideally relevant experience within clinical management or project management roles.
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Interested in hearing more about Worldwide or our roles? Check out our careers page at www.worldwide.com/careers!
Employment Type: Regular
Community / Marketing Title: Associate Medical Monitor, Medical Director, CNS, Americas (US, Canada, LATAM)
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.