Sr. Associate - Records Information Management & Systems (RIMS)

Spectraforce

US


a month ago

Remote

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Job Description

Title: Sr. Associate - Records Information Management & Systems (RIMS)
Duration: 12 Months
Location: Remote

Looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone preferred.

Key responsibilities include:
• Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives.
• Work with stakeholders to gather requirements and develop solutions.
· Provide Subject Matter Expertise in Veeva Vault Configuration and Regulatory Processes to
a global user base.
• Develop and deliver training materials and presentations to a global audience.
• Author/review/approve quality Regulatory Information Management & Systems documents
· Analysis of the existing documentation and process explore avenues to simplify and
streamline.
• Provide operational support for Regulatory Data Management, Submissions, and EU CTR.
• Develop and implement process improvements and automation.
• Lead and/or support team projects.
· Organize and present data in user-friendly, graphical, interactive informational summaries
that illustrate how GRAAS is performing and allow us to understand and improve business
performance
• Utilize the Six Sigma method to support team processes.

Must have:
  • As far as overall background, our team would need someone who is comfortable with learning new systems,
  • has experience managing content in SharePoint,
  • has working experience with the Six Sigma method and
  • project management experience.

As the Global Labeling Lead product lead for marketed products, leads product-specific global labeling development and maintenance activities throughout a product?s life cycle. Specific responsibilities include: development and maintenance of Core Data Sheets and USPIs/ PPIs, facilitation of corporate review and approval activities for CDS and regional labeling, including regional deviations from the CDS. Ensures alignment of labeling strategy across products; collaborates with other Product Leads and functional area representatives to ensure adherence to established """" processes and corporate standards; coordinates corporate review and approval of cross-product issues within the scope of assigned products/franchises at the discretion of Director. Leads cross-functional teams in the development and maintenance of TPLs, dCDSs, CDSs, USPIs/PPIs/MGs/DHCP letters and Global Negotiation Documents (GNDs); facilitates implementation discussions of FDA approved product labeling; creates and maintains cumulative annotated labeling history documents for assigned products/regions; collaborates with regional affiliates and Business Partner representatives in the development and maintenance of regional drug product labeling; manages labeling commitments for Business Partners as delineated in partnership/service agreements; maintains awareness of regulatory legislation pertaining to labeling and assesses and communicates its impact on the business and products of the company; reviews and assesses impact of draft legislation; provides input on ""/industry comments Technical: Proficiency in Microsoft Suite (Outlook, Word, Excel, PowerPoint) Technical competency for data entry into electronic document management systems, Sharepoint sites and other databases/trackers 

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: $35.00/hr. 

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: $30.00/monthly.

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