Senior Documentation Specialist - III Location: Hybrid (Rahway, NJ 07065/Upper Gwynedd, PA 19454) Duration: 15 Months
Additional: 3 days onsite required. Candidate can be local Upper Gwynedd, PA location & or Rahway, NJ.
Qualifications: 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. Responsibilities: Supports the operational aspects of procedural documentation management and advises on documentation strategy for client’s Global Regulatory Affairs & Clinical Safety (GRACS) organization within Client Research Laboratories (MRL). 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.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.
