About the roleThe 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 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 CandidateAnalyticalAdaptableDetail OrientedProblem SolverWhat You'll DoAct 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 NeedMinimum bachelor’s degree in health-related science and/or healthcare credentials (RN, PharmD, MD); advanced degree preferredAt least 5+ years of relevant clinical research experience, preferably in medical monitoring or equivalent combination of education and experienceWillingness and ability to travel domestically and internationally as needed for business meetings, bid defenses, trainings and/or industry eventsExperience in EAP / CUP / NPP is preferredProven experience in protocol development, implementation, and interpretationExperience in safety monitoring, adverse event reporting, and medical data review in the context of clinical trialsIn-depth knowledge of clinical trial design, regulatory requirements, and drug development processesComputer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPointStrong leadership, communication, and collaboration skills across diverse teams and stakeholdersProven analytical, problem-solving, and decision-making abilities in complex healthcare settingsHighly organized, with the ability to work independently and as part of a teamWhat We OfferMedical, dental, and vision insurance, FSA, HSAVoluntary short-term and long-term disability insuranceVoluntary life insurance401K safe harbor plan and company matchPaid vacation, holiday, and sick timePaid maternity & paternity leaveWhat sets us apartWEP 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 TeamWEP has many initiatives to encourage wellness, growth and development, and team relationships.We're Committed to DEIAcceptance, recognition, and engagement are the core of WEP Clinical’s DEI values. The company is committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.Our services includeAccess ProgramsClinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and CommercializationWork environmentWEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.Equal opportunityWEP Clinical is an equal-opportunity employer and does not unlawfully discriminate against employees or applicants for employment based on 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.
