Medical Affairs Associate
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 Associate 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 Associate 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 Associate, 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 agencies, and internal/external teams, ensuring protocol clarity and consistent interpretation.
Monitor clinical trials and Expanded Access Programs (EAPs) for participant safety, data accuracy, and protocol compliance, addressing medical issues as needed.
Participate in site selection by evaluating investigator experience and conducting calls to review inclusion/exclusion criteria and support patient recruitment.
Serve as the lead medical expert on the trial protocol, ensuring understanding and adherence across investigators, study teams, and stakeholders.
Review and assess adverse events (AEs) and serious adverse events (SAEs), ensuring proper documentation, timely reporting, and causality assessment.
Collaborate with Data Safety Monitoring Boards (DSMBs) and safety committees to oversee participant safety and evaluate ongoing trial data.
Provide protocol and therapeutic training to investigators, site staff, and cross-functional teams to ensure consistent understanding and compliance.
Participate in investigator meetings and site initiation visits, clarifying protocol-related issues and addressing medical questions.
Contribute medical expertise to study documents including protocols, treatment guidelines, and trial design elements.
Ensure study conduct aligns with the protocol, resolving deviations and maintaining the scientific and ethical integrity of the trial.
Collaborate with clinical operations, regulatory, pharmacovigilance, and project management teams to ensure GCP compliance and timely safety reporting.
Support business development and cross-functional teams by providing medical input in bid proposals, client meetings, and protocol-related discussions.
What You'll Need:
Minimum bachelor’s degree in health-related science and/or healthcare credentials (RN, PharmD, PHD,MD); advanced degree preferred
At least 1-2+ years of relevant clinical research experienceor equivalent combination of education and experience
Experience in Therapeutic Areas such as CNS, Rare Diseases and/or Oncology, is a plus
Willingness and ability to travel domestically and internationallyas needed for business meetings, bid defences, trainings and/or industry events (5-10%)
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
Exceptional leadership, communication, and interpersonal skills to collaborateeffectively with diverse teams and external stakeholders
Strong analytical and problem-solving abilities to make data-driven decisions and navigate complex challenges in the healthcare sector
Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment required
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.
#LI-Remote
About the job
Apply for this position
Medical Affairs Associate
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 Associate 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 Associate 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 Associate, 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 agencies, and internal/external teams, ensuring protocol clarity and consistent interpretation.
Monitor clinical trials and Expanded Access Programs (EAPs) for participant safety, data accuracy, and protocol compliance, addressing medical issues as needed.
Participate in site selection by evaluating investigator experience and conducting calls to review inclusion/exclusion criteria and support patient recruitment.
Serve as the lead medical expert on the trial protocol, ensuring understanding and adherence across investigators, study teams, and stakeholders.
Review and assess adverse events (AEs) and serious adverse events (SAEs), ensuring proper documentation, timely reporting, and causality assessment.
Collaborate with Data Safety Monitoring Boards (DSMBs) and safety committees to oversee participant safety and evaluate ongoing trial data.
Provide protocol and therapeutic training to investigators, site staff, and cross-functional teams to ensure consistent understanding and compliance.
Participate in investigator meetings and site initiation visits, clarifying protocol-related issues and addressing medical questions.
Contribute medical expertise to study documents including protocols, treatment guidelines, and trial design elements.
Ensure study conduct aligns with the protocol, resolving deviations and maintaining the scientific and ethical integrity of the trial.
Collaborate with clinical operations, regulatory, pharmacovigilance, and project management teams to ensure GCP compliance and timely safety reporting.
Support business development and cross-functional teams by providing medical input in bid proposals, client meetings, and protocol-related discussions.
What You'll Need:
Minimum bachelor’s degree in health-related science and/or healthcare credentials (RN, PharmD, PHD,MD); advanced degree preferred
At least 1-2+ years of relevant clinical research experienceor equivalent combination of education and experience
Experience in Therapeutic Areas such as CNS, Rare Diseases and/or Oncology, is a plus
Willingness and ability to travel domestically and internationallyas needed for business meetings, bid defences, trainings and/or industry events (5-10%)
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
Exceptional leadership, communication, and interpersonal skills to collaborateeffectively with diverse teams and external stakeholders
Strong analytical and problem-solving abilities to make data-driven decisions and navigate complex challenges in the healthcare sector
Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment required
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.
#LI-Remote