Person2Person, LLC
 | |  | |  | |  |
| Clinical SOP Writer Based in Northern, NJ |
| Outstanding Contract opportunity with a global pharmaceutical Company focused on multiple therapeutic areas including Neurology, Oncology and Critical Care. They continue to move forward with an entry into biologics with the development of therapeutic antibodies and other such agents, which contributes to their innovate drug discovery process. Be a part of this global market leader! |
| SCOPE & DUTIES |
Provide SOP writing, process flow development and other documents development as needed to support
the development and/or revision of Clinical Development and Regulatory Affairs (CDRA) Procedural
Documents (SOPs, Work Instructions, Forms/Templates, Job Aids or Guidelines)
Responsibilities
• Revise current SOPs based on process changes and new SOP templates
• Convert existing Work Practices into SOPs or Work Instructions based on appropriate document type.
• Develop process maps based on SOP processes
• Perform QC checks on document format and style as needed to support Sr. Manager, Clinical
Compliance and Training (CCT).
• Work with functional management and Head CCT on the development of SOP transition plans as
needed to assure successful implementation of new processes.
• Work with Sr. Manager and functional management to assure that a Procedural Document review team
is established and facilitate the draft review process within Please Review.
the development and/or revision of Clinical Development and Regulatory Affairs (CDRA) Procedural
Documents (SOPs, Work Instructions, Forms/Templates, Job Aids or Guidelines)
Responsibilities
• Revise current SOPs based on process changes and new SOP templates
• Convert existing Work Practices into SOPs or Work Instructions based on appropriate document type.
• Develop process maps based on SOP processes
• Perform QC checks on document format and style as needed to support Sr. Manager, Clinical
Compliance and Training (CCT).
• Work with functional management and Head CCT on the development of SOP transition plans as
needed to assure successful implementation of new processes.
• Work with Sr. Manager and functional management to assure that a Procedural Document review team
is established and facilitate the draft review process within Please Review.
| REQUIREMENTS |
• Bachelors with a minimum of 5 years in a Pharmaceutical/Biotech company within Clinical Development
• Demonstrated proficiency in writing SOPs in a GCP environment.
• Demonstrated proficiency in Microsoft Word and Visio
• Understanding of Clinical Development processes primarily related to Clinical Trials, Data
Management, etc.
• Excellent communication skills and ability to work with people in all levels of the organization
• Demonstrated skills in working with minimal supervision
• Experience in Pharmacovigilience a plus
•Experience with Qumas Document Management System a plus.
• Demonstrated proficiency in writing SOPs in a GCP environment.
• Demonstrated proficiency in Microsoft Word and Visio
• Understanding of Clinical Development processes primarily related to Clinical Trials, Data
Management, etc.
• Excellent communication skills and ability to work with people in all levels of the organization
• Demonstrated skills in working with minimal supervision
• Experience in Pharmacovigilience a plus
•Experience with Qumas Document Management System a plus.
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |