This will be a 100% remote role. Our team is looking for a candidate who is able to work standard hours (ex. 7a-4p or 8am-5p etc.), with EST time zone preferred. The candidate would need to have flexibility to shift their hours to start and end their day at a later time, if additional support is needed for the PST time zone.
CW Senior Associate role within RIMS Team (GRAAS Organization). In order to support our team's ongoing projects, we are seeking a candidate who is comfortable with learning new systems, has experience managing content in SharePoint, has working experience with the Six Sigma methodology, process mapping and project management experience. Regulatory affairs knowledge will be considered. Any Regulatory certifications/qualifications will add value. Technical understanding of Regulatory systems will be desirable. Knowledge and interest in SQLs/Databases will also be considered.
Day to Day Responsibilities: Key Activities All, or a subset of the following: • Maintain Regulatory document management and tracking systems • Support Activities for Clinical Trial and Marketing Application submissions/Health Authority correspondence • Data Management Point of contact between Regulatory Representatives/CMC, publishing teams and vendor • Support activities to manage the Protocol Amendment New Investigator (PANI) submissions and PI updates/additions • Ensuring Regulatory compliance with SOPs and Regulatory authorities • Provide training, mentoring and support to Data Management team members and other functional areas, including vendors • Collaboration with external partners/outsourced CROs
Must have Skills: Must be able to speak to technical expertise-SharePoint working experience, excel and Smartsheet, Veeva vault hands on working experience (This is more important than a strong level experience with regulatory experience but should still have a few years of regulatory experience (i.e 1-2 yrs) Interpersonal communications skills Multitasker - able to juggle multiple priorities - ability to work independently
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.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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: $31.00/hr.
