Wepclinical13mo ago

Medical Affairs Specialist

CanadaRemoteFull-Timemid

Other

1 views0 saves0 applied

Apply Now

Quick Summary

Overview

Technical Tools

excelms-office

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Medical Affairs Specialist collaborates with the Medical Affairs department and other operational teams to ensure WEP Clinical provides the highest standards of ethical and scientific rigor in the execution of all projects. The Medical Affairs Specialist serves as the primary support to Medical Managers and Medical Directors in the execution of clinical trials and different early access programs, playing a relevant role in ensuring their accuracy, integrity, and successful completion. As a Medical Affairs Specialist, you will provide scientific support, medical data collection and analysis to enable different activities in the department, such as medical monitoring, pharmacovigilance, site selection/ feasibility, study documents development and our home-health and virtual solutions services. This position encompasses a variety of roles and integrates multiple functions, supporting the Medical Affairs Department in a broad spectrum of activities.

Analytical

Adaptable

Detail Oriented

Problem Solver

Act as the primary medical contact for investigators, regulatory bodies, and internal/external stakeholders, ensuring consistent interpretation and clarification of study protocols.

Oversee clinical trials and/or Expanded Access Programs (EAP) to ensure participant safety, data accuracy, and adherence to protocols, addressing medical issues as they arise.

Support investigator site selection by evaluating qualifications, experience, and suitability during feasibility discussions and selection processes.

Lead and participate in investigator calls to discuss inclusion/exclusion criteria and provide tailored support to optimize site engagement and patient recruitment.

Serve as the lead medical expert on study protocols, ensuring full comprehension and adherence across all involved parties.

Conduct and contribute to investigator meetings, site initiation visits, and study-related training sessions to explain protocol requirements and resolve medical concerns.

Provide continuous medical training and support to investigators, site personnel, and internal teams, ensuring alignment with study objectives and therapeutic area knowledge.

Review adverse events (AEs) and serious adverse events (SAEs), perform causality assessments, and ensure accurate, timely safety reporting.

Collaborate with Data Safety Monitoring Boards (DSMBs) and other safety committees to monitor ongoing trial safety and provide medical oversight.

Contribute medical expertise to the development of study documents, including protocols, treatment guidelines, and methodology, ensuring scientific rigor and ethical compliance.

Ensure study conduct aligns with protocol and regulatory requirements by identifying, classifying, and resolving deviations in collaboration with cross-functional teams.

Represent Medical Affairs in external engagements such as bid proposals, defense meetings, and client presentations, while supporting internal teams with protocol-related guidance.

Minimum bachelor’s degree in health-related science and/or healthcare credentials (RN, PharmD, MD); advanced degree preferred

At least 5+ years of relevant clinical research experience, preferably in medical monitoring or equivalent combination of education and experience

Willingness and ability to travel domestically and internationally as needed for business meetings, bid defenses, trainings and/or industry events

Experience in EAP / CUP / NPP is preferred

Proven experience in protocol development, implementation, and interpretation

Experience in safety monitoring, adverse event reporting, and medical data review in the context of clinical trials

In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes

Computer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint

Strong leadership, communication, and collaboration skills across diverse teams and stakeholders

Proven analytical, problem-solving, and decision-making abilities in complex healthcare settings

Highly organized, with the ability to work independently and as part of a team