Wepclinical13mo ago

Medical Affairs Specialist

CanadaRemoteFull-Timemid

Other

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Quick Summary

Overview

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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 WEP Clinicsl 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

Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

What We Offer:

For international hires employed through an employer-of-record partner, benefits and leave offerings may vary based on local regulations and regional employment practices.

What Sets Us Apart:

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.

How We Work at WEP Clinical:

At WEP Clinical, we look for individuals who are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

Data Privacy Notice:

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Job Applicant Privacy Notice: https://www.wepclinical.com/privacy-policy/

How to Apply:

To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.

To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.

For your safety, please note:

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any stage of recruitment

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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