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. 

The Ideal Candidate:

• Analytical

• Adaptable

• Detail Oriented

• Problem Solver

What You'll Do:

• 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.

What You'll Need:

• 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

What We Offer:

Medical, dental, and vision insurance, FSA, HSA

Voluntary short-term and long-term disability insurance

Voluntary life insurance

401K safe harbor plan and company match

Paid vacation, holiday, and sick time

Paid maternity & paternity leave

What sets us apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

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 that we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialization

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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