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 scientific and medical expertise 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 the study protocol as well as medical management activities for patients during the course of the trial. Pharmacovigilance activity for adverse event analyses and reporting and a medical writing group are integral part of the service offering. Medical Affairs also partner with other functional groups within the Worldwide organization, the generation of statistical and clinical reports at study conclusion, and scientific/medical assistance in the preparation of study protocols and regulatory submissions.

What you will do (Medical Director)

• Work with global and diverse teams and sponsors from biotech and pharma industries to provide medical expertise, consultation, and support to project teams. Engage with Worldwide teams and our sponsors from protocol development to regulatory submission.
• Provide Global and/or Regional Medical Monitoring support to assigned clinical studies, including medical management and oversight; training project teams on therapeutic indications and protocol; review of study documents (protocols, safety data, clinical study reports), collaborate with pharmacovigilance to review and process Serious Adverse Events. Represent Worldwide Medical Affairs at investigator and project team meetings.
• Collaborate with Worldwide Business Development to review and develop proposals, assess feasibility, attend general capabilities, or bid defense meetings.
• Engage in company and department initiatives, contribute to and participate in company and Medical Affairs programs, trainings and marketing initiatives. Assist in the annual attainment of departmental budget reviews, revenue targets and any other activities.
• Maintain working knowledge of GCPs and regulatory requirements relating to clinical development and safety. Assure compliance with ethical, legal and regulatory standards. Obtain medical expertise and knowledge of relevant projects, indications through review of research literature, attendance of relevant internal and external meetings/conferences.

What you will bring to the role

• Medical expertise and good medical judgement. Understanding of medical and clinical research norms and practices
• Strong organizational and interpersonal skills in a fast-paced and rapidly changing environment. Ability to work independently and as a team member, to exercise independent judgment with sensitivity to decisions requiring supervisory approval, to handle multiple tasks, including rapid response in review of information and documents
• Excellent written and verbal English and communication skills. Advanced skills in MS Office applications including Microsoft Word, Excel and PowerPoint, willing to learn new technical systems
• Knowledge and understanding of ICH, GCP and FDA or EU directive regulations (as applicable) as well as local regulatory requirements

Your background

• Doctor of medical or osteopathic medicine (MD or OD) degree from an accredited medical education institution, preferably with specialization in the advertised therapeutic area
• At least 2 years of medical monitoring or study physician role in clinical research or related industry
• Valid passport and ability to travel as required.