Job Name: Clinical Trials Disclosure Specialist
Location: Giralda Farms, NJ or Lawrenceville, NJ
Contractor Work Model: Role is 50% onsite

 A Leading pharmaceutical company, with locations in NJ is looking to bring on a Clinical Trials Disclosure Specialist to join their team. To be a part of this groundbreaking work, please apply.
Requirements:
• BA/BS or MA/MS in scientific or medical field
• 2-3 years of document redaction and 3+ years relevant work experience in a scientific or medical field with BA/BS
Must Have List:
2+ years in the Biopharma space
2+ years of Project Management experience
1+ years of medical/scientific writing experience
2+ years of document redaction/Clinical Trial transparency experience
QC experience

Full Job Description:
The Clinical Trial Disclosure Senior Specialist will provide the operational support of:
• Redaction of clinical trial documents in accordance with evolving global regulations.
Key business partners are Clinical Development/Early Development Leads, Global Development Operations, Global Biostatisticians, Publications, Information Technology, Alliance Partners, Medical Writing, and Submission Managers.

Key Responsibilities and Major Duties:
• Manage and Coordinate redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI), EU Clinical Trial Regulation, and other global regulations.
• Collaborate with Global Development Operations, Global Biostatisticians, Medical Writing, Submission Managers, and other stakeholders to operationalize redaction requirements
• Provide vendor oversight to support document redactions
• Work with IT, as needed, to implement technology solutions related to clinical trial disclosure
• Manage and track redaction book-of-work; compile and report on volume and performance metrics
• Provide operational support to CT Results Specialists, as required
• Assists in monitoring the global regulatory environment and maintains working knowledge of disclosure requirements
• Communicates with internal and external stakeholders to improve on processes and manage unmet need
• Trains new staff and develops job aids, work instructions, and user guides, as needed

Candidate requirements:
• BA/BS or MA/MS in scientific or medical field
• 2-3 years of document redaction and 3+ years relevant work experience in a scientific or medical field with BA/BS
• Deep understanding of US/Canada and EU requirements for clinical trial disclosure as well as other related policies (ICMJE, PhRMA/EFPIA principles for responsible data sharing, etc.)
• Familiarity and comfortability working with and discussing scientific data
• Project and stakeholder management experience
• Demonstrated ability to work independently and seek out support when needed
• Exceptional written and oral communication skills
• Strong organizational skills with the ability to multitask and prioritize
 

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.