Medical/Vaccine Regulatory Management Professional at ANSER Corporation in Falls Church, VA
Analytic Services, Inc. (ANSER) is seeking professionals for several areas involving vaccine related regulatory matters including roles of management, PMO support, policy analyst, manufacturing, and writer in support of COVID-19 efforts in the DC metro area with positions in the DC/Maryland area supporting a client in Fort Detrick. Physical presence in the Ft. Detrick area is likely not a requirement each day. Position
Responsibilities:
Positions include:
Regulatory Manager Bachelors +10 years' experience :
Manage subset of regulatory strategy execution and regulatory operations, including filings; liaise with regulators and SMEs as needed. eIT PMO Support Bachelors +8 years' experience :
Work with senior directors and regulatory affairs managers to manage regulatory documentation through the document life-cycle on virtual platforms including document management systems. Coordinate across groups to safeguard regulatory documents. Assist with the development and/or update of regulatory document review, approval, distribution, and storage guidelines. Coordinate with the PMO office to generate tailored document workflows for staffing regulatory documents for comment. Manager and Policy Analyst Bachelors +10 years' experience :
Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines). Draft, manage, maintain and retain regulatory and quality documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with regulatory agencies, official briefing packages, submissions, and other relevant regulatory documentation) in the in accordance with approved business rules in the assigned electronic document management system. Manager, CMC/Manufacturing Bachelors +10 years' experience :
Provide expert analysis and advice on Chemistry, Manufacturing, and Controls (CMC) matters and the development, management and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and organizational quality standards, build and maintenance of Quality KPIs/metrics, and documentation and data controls programs for maintaining compliance to the regulations, guidelines and the organization directives, and that documentation is effectively implemented, controlled, maintained, stored, archived, protected and retrievable. Conduct required site visits of performers in order to assist in monitoring performance and quality standards, provide technical oversight, and assess capabilities and program progress. Provide regulatory expertise to support the design, development, procurement, commissioning, installation, qualification, and validation of single use systems technologies in relation to medical countermeasure manufacturing. Manager, Portfolio Bachelors +10 years' experience :
Under the senior director lead the development and implementation of regulatory strategies and processes to integrate regulatory/quality support into the product life-cycle for all COVID products. Develops, implements and maintains a quality management system and activities for each product that falls within the portfolio to ensure compliance with laws, regulations and policies. Medical Writer Bachelors +5 years' experience :
Work with the senior leadership and regulatory affairs managers to draft, manage, maintain and retain regulatory and quality documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, regulatory SOPs, study protocols/reports, correspondence with regulatory Agencies, official briefing packages, submissions, and Summary of Safety and Clinical Performance (SSCPs)) in accordance with approved business rules in the assigned electronic document management system. Maintain a product tracker to ensure regulatory deadlines are met for annual reports, FDA requests for information, and overall product submission timelines. Assist in the revision of procedures (e.g., brief development and internal routing procedures) and policies, submitting all recommendations to leadership for approval. Required Skills/Education/
Experience:
Must posses a Secret level US government security clearance See individual position for minimum degree and years of experience Equivalencies for degree/years of experience considered Desired Skills/Education/
Experience:
Experience supporting the US government medical community
Salary Range:
$80K -- $100K
Minimum Qualification
Government & MilitaryEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Positions include:
Regulatory Manager Bachelors +10 years' experience :
Manage subset of regulatory strategy execution and regulatory operations, including filings; liaise with regulators and SMEs as needed. eIT PMO Support Bachelors +8 years' experience :
Work with senior directors and regulatory affairs managers to manage regulatory documentation through the document life-cycle on virtual platforms including document management systems. Coordinate across groups to safeguard regulatory documents. Assist with the development and/or update of regulatory document review, approval, distribution, and storage guidelines. Coordinate with the PMO office to generate tailored document workflows for staffing regulatory documents for comment. Manager and Policy Analyst Bachelors +10 years' experience :
Possess and maintain a mastery of relevant drug and/or biologics and/or devices, and/or combination medical product laws, regulations and policies (e.g. FDA regulations, ICH guidelines). Draft, manage, maintain and retain regulatory and quality documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, study protocols/reports, correspondence with regulatory agencies, official briefing packages, submissions, and other relevant regulatory documentation) in the in accordance with approved business rules in the assigned electronic document management system. Manager, CMC/Manufacturing Bachelors +10 years' experience :
Provide expert analysis and advice on Chemistry, Manufacturing, and Controls (CMC) matters and the development, management and improvement of quality systems and procedures to ensure compliance with all applicable laws, regulations and organizational quality standards, build and maintenance of Quality KPIs/metrics, and documentation and data controls programs for maintaining compliance to the regulations, guidelines and the organization directives, and that documentation is effectively implemented, controlled, maintained, stored, archived, protected and retrievable. Conduct required site visits of performers in order to assist in monitoring performance and quality standards, provide technical oversight, and assess capabilities and program progress. Provide regulatory expertise to support the design, development, procurement, commissioning, installation, qualification, and validation of single use systems technologies in relation to medical countermeasure manufacturing. Manager, Portfolio Bachelors +10 years' experience :
Under the senior director lead the development and implementation of regulatory strategies and processes to integrate regulatory/quality support into the product life-cycle for all COVID products. Develops, implements and maintains a quality management system and activities for each product that falls within the portfolio to ensure compliance with laws, regulations and policies. Medical Writer Bachelors +5 years' experience :
Work with the senior leadership and regulatory affairs managers to draft, manage, maintain and retain regulatory and quality documentation (e.g. TPPs, regulatory strategies, regulatory assessments or whitepapers, regulatory SOPs, study protocols/reports, correspondence with regulatory Agencies, official briefing packages, submissions, and Summary of Safety and Clinical Performance (SSCPs)) in accordance with approved business rules in the assigned electronic document management system. Maintain a product tracker to ensure regulatory deadlines are met for annual reports, FDA requests for information, and overall product submission timelines. Assist in the revision of procedures (e.g., brief development and internal routing procedures) and policies, submitting all recommendations to leadership for approval. Required Skills/Education/
Experience:
Must posses a Secret level US government security clearance See individual position for minimum degree and years of experience Equivalencies for degree/years of experience considered Desired Skills/Education/
Experience:
Experience supporting the US government medical community
Salary Range:
$80K -- $100K
Minimum Qualification
Government & MilitaryEstimated Salary: $20 to $28 per hour based on qualifications.
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