Clinical Trials Disclosure Specialist | Madison, NJ

Job Title: Clinical Trials Disclosure Specialist Duration: 12 Month Contract (Possible extension based on work performance) Location: Madison, NJ 07940 Hybrid Position (CW can work from Giralda Farms, NJ. or Lawrenceville, NJ) Job Description: 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 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 #J-18808-Ljbffr Sunrise Systems