Job Description

Immediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 24-34389

Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• The role is responsible for supporting GRACS Document Owners and Functional Areas in the development, revision, implementation and maintenance of their procedural documentation (policies, standard operating procedures and supporting documents) related to global Regulatory Affairs and/or Pharmacovigilance activities.
• The role collaborates with Business Process Leads, Functional Leads, Document Owners, and Subject Matter Experts (SMEs) to ensure the documentation conforms to MRL standards for classification within a prescribed documentation hierarchy, and adequately reflects the intended processes to support GRACS business activities.

Key Requirements and Technology Experience:

• Education: Must have a Bachelor's degree or higher for this role.
• Required Experience: 6+yrs industry experience and familiarity with the following:
• Support and manage the creation/revision of Regulatory Affairs and Global Pharmacovigilance Procedural Documentation (e.g., Standard Operating Procedures, Job Aids, Forms, Process Guides, and User Manuals).
• Develop and manage integrated project plan.
• Lead &/or complete documentation impact assessments to identify impact of process changes across the library of documents.
• Support process owners in the development of process maps in support of procedural documentation development.
• Facilitates documents through draft, review and approval cycles to meet required timeframes for release and implementation.
• Conduct periodic assessment of procedural content to ensure adherence to format, content, and style guidelines, and identify improvement opportunities to Process Owners and Document Owners Support and manage the overall documentation change control process and related systems for document access, review, and approval.
• Maintain and organize current effective documentation within logical groupings/categories to facilitate ease of access for GRACS end users.
• Support and manage requests for documentation for GRACS internal audits and inspections for process documentation.
• Veeva Vault Quality Docs experience preferred.

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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