Documentation Specialist
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Are you passionate about making a meaningful impact in patients' lives by supporting access to innovative therapies? At WEP Clinical, we are committed to helping patients gain early access to life-changing treatments. We offer a collaborative environment where every role contributes to our mission, and opportunities for growth and impact are supported. Join our team and be part of a company that advances medical research and puts patients first.
Role Objectives:
The WEP Clinical Documentation Specialist is responsible for managing program-related documentation in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH guidelines, and study-specific Trial Master File (TMF) plans. This role also includes processing and maintaining accurate shipping documentation.
The Ideal Candidate:
Detail-oriented
Highly Organized
Adaptable
What You'll Do:
Track, obtain, and file shipping-related documents in line with WEP and program-specific requirements.
Process shipment orders (if applicable) and ensure accurate documentation.
Collaborate with internal teams to support order processing and document management.
Set up, maintain, and close out the electronic Trial Master File (eTMF) per WEP processes, sponsor requirements, and regulations.
Maintain systems and tools for tracking and transmitting TMF documents.
Conduct quality checks (QC) on eTMF documents and any required paper originals.
Perform regular eTMF content reviews and provide reports to project teams and management.
Scan, label, and upload documents to internal systems for easy access and retrieval.
Ensure compliance with WEP privacy, security, and document retention standards.
Support internal and external audits to ensure adherence to SOPs, policies, and GCP guidelines.
Maintain study status trackers and other documentation tools as assigned.
Support long-term document storage strategies and help train staff on documentation practices.
What You'll Need:
Bachelor’s degree preferred.
2–3 years of experience in order processing and documentation management systems preferred.
Familiarity with clinical study documentation, including QC, SOPs, GCP guidelines, and archiving best practices.
Experience with clinical trial electronic databases preferred.
Proven ability to meet quality and timeline objectives.
Strong computer skills, including proficiency in Microsoft Office.
Skilled in formatting and publishing documents, and maintaining tracking systems.
Able to coordinate document review and finalization across multiple stakeholders.
Quick to learn new software programs and databases.
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.
Documentation Specialist
To see similar active jobs please follow this link: Remote Writing jobs
Are you passionate about making a meaningful impact in patients' lives by supporting access to innovative therapies? At WEP Clinical, we are committed to helping patients gain early access to life-changing treatments. We offer a collaborative environment where every role contributes to our mission, and opportunities for growth and impact are supported. Join our team and be part of a company that advances medical research and puts patients first.
Role Objectives:
The WEP Clinical Documentation Specialist is responsible for managing program-related documentation in compliance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), ICH guidelines, and study-specific Trial Master File (TMF) plans. This role also includes processing and maintaining accurate shipping documentation.
The Ideal Candidate:
Detail-oriented
Highly Organized
Adaptable
What You'll Do:
Track, obtain, and file shipping-related documents in line with WEP and program-specific requirements.
Process shipment orders (if applicable) and ensure accurate documentation.
Collaborate with internal teams to support order processing and document management.
Set up, maintain, and close out the electronic Trial Master File (eTMF) per WEP processes, sponsor requirements, and regulations.
Maintain systems and tools for tracking and transmitting TMF documents.
Conduct quality checks (QC) on eTMF documents and any required paper originals.
Perform regular eTMF content reviews and provide reports to project teams and management.
Scan, label, and upload documents to internal systems for easy access and retrieval.
Ensure compliance with WEP privacy, security, and document retention standards.
Support internal and external audits to ensure adherence to SOPs, policies, and GCP guidelines.
Maintain study status trackers and other documentation tools as assigned.
Support long-term document storage strategies and help train staff on documentation practices.
What You'll Need:
Bachelor’s degree preferred.
2–3 years of experience in order processing and documentation management systems preferred.
Familiarity with clinical study documentation, including QC, SOPs, GCP guidelines, and archiving best practices.
Experience with clinical trial electronic databases preferred.
Proven ability to meet quality and timeline objectives.
Strong computer skills, including proficiency in Microsoft Office.
Skilled in formatting and publishing documents, and maintaining tracking systems.
Able to coordinate document review and finalization across multiple stakeholders.
Quick to learn new software programs and databases.
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.