Documentation Analyst
Spectraforce
US
Remote
5 months ago
Job Description
Job title: Documentation Analyst
This position is REMOTE
Duration: 06 Months
Work Schedule: Mon - Fri, Business Hours
Based out of New Brunswick NJ
Summary:
This role will be responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments. This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time. This candidate is expected to have a good understanding of regulatory guidelines.
Job Description:
Manage document preparation of CMC regulatory submission documents to client's standards and ensure final document compliance to ensure submission content meets formatting requirements.
Manage the logistical process in the authoring system for CMC regulatory submissions.
This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams.
Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure.
Author CMC elements of regulatory filings with supervision.
Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.
Education and Experience Required:
Bachelor’s degree in a relevant discipline with a minimum of 4 - 7 years relevant experience. OR a Masters degree with 1-3 years relevant experience.
Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams.
Must possess excellent time management and organizational skills and have the ability to navigate in electronic systems.
Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
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: $35.00/hr.
This position is REMOTE
Duration: 06 Months
Work Schedule: Mon - Fri, Business Hours
Based out of New Brunswick NJ
Summary:
This role will be responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments. This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time. This candidate is expected to have a good understanding of regulatory guidelines.
Job Description:
Manage document preparation of CMC regulatory submission documents to client's standards and ensure final document compliance to ensure submission content meets formatting requirements.
Manage the logistical process in the authoring system for CMC regulatory submissions.
This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams.
Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure.
Author CMC elements of regulatory filings with supervision.
Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.
Education and Experience Required:
Bachelor’s degree in a relevant discipline with a minimum of 4 - 7 years relevant experience. OR a Masters degree with 1-3 years relevant experience.
Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams.
Must possess excellent time management and organizational skills and have the ability to navigate in electronic systems.
Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines.
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
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: $35.00/hr.