Archivist and Technical Writer Associate
Pioneer Hi-Bred International - Wilmington, MA

This job posting is no longer available on The Scientist Careers. Find similar jobs: Archivist Technical Writer Associate jobs - Pioneer Hi-Bred International jobs

This position will serve as the assistant Good Laboratory Practice [GLP] archivist to ensure accurate record keeping and organized storage/control of regulatory records critical to maintaining registrations. He/she will assist in maintaining and organizing vital regulatory documentation in support of global product submissions and may recommend procedure improvements and/or participate in the development of documentation practices to modify procedures with changing circumstances and situations. He/she will assist in identifying process issues, recommending and implementing corrections or process changes.

This position will also assist in providing technical writing support to the regulatory organization members. This may include assisting with format review, template generation, assistance with figures and table generation and peer review coordination of technical documentation for regulatory science studies according to agreed timelines. Technical writing support for regulatory science studies is a critical task supporting submissions for approvals of biotechnology products.

Additionally, this position will assist in the maintenance and operation of the electronic document management system (DM). This includes end user training, support and troubleshooting.

1)Serves as the regulatory Assistant GLP archivist and coordinates the compliant daily operations of the GLP archive.

a) Responsible for secure storage and archiving of critical records in support of global product registrations. May be required to modify procedures as needed with continuously changing circumstances and situations.

b) Responsible for GLP archiving of Regulatory study records, historical GLP personnel files, facility records, etc. May be required to modify procedures, including SOPs, as needed to adapt to a changing Regulatory environment.

c) Assist with the maintenance of all necessary documentation to demonstrate compliance with government regulations and company policy. May require the determination of appropriate course of action to address and participate in the development and/or modification of procedures to accommodate changing regulatory circumstances and situations.

d) Assist with the development, review and revision of archive processes and the documentation of these processes for departmental reference.

e) Coordinate record transfer to and from the long term storage facility, Pioneer research and contract research organizations [CROs].

f) Work with Quality Assurance Unit [QAU] to continually audit and improve the archive systems and routinely report findings and resolutions to the Senior GLP Archivist.

g) Maintain the archive record of laboratory reference substances.

h) Assist in maintaining the electronic data Archive system.

2) Ensure the efficient operation and maintenance of document and record management process control systems for Regulatory.

a) Processing and maintenance of study protocols, amendments, deviations and documents provided by study personnel while studies are on-going.

b) Responsible for the availability and internal distribution of controlled study documents [i.e. protocols, amendments, reports, etc.].

c) Assist in maintaining and supporting the document and record management process control systems for Regulatory while maintaining compliance with company policies and government regulations.

3) Serve as Technical Writing Support through assisting in drafting and reviewing technical reports with Regulatory scientists and managers to meet deadlines for product submissions to regulatory agencies.

a) Review protocols and amendments to ensure proper formatting.

b) Ensure final reports are compliant with PR Notice 86-5 reporting requirements.

c) Create document templates for study directors/authors to use.

d) Figure labeling.

e) Compiling figures and tables to be used in reports and protocols.

f) Reviewing and distributing draft documents for peer review

g) Provide writing and computer guidance to Regulatory staff

4) Serve as the Technical Support contact for the Wilmington regulatory electronic

document management system (DM).

a) Provide end user support and troubleshooting issues with DM functionality. Determine when to escalate to manager and/or IT Support.

b) Provide end user support documentation.

c) Schedule and perform DM end user training for users.

d) Perform DM system testing under manager supervision to verify correct functional operation of routine software releases and major upgrades.

e) Recommend changes in documentation processes, assist in the development of documentation practices and utilization of established procedures to insure information is organized in an efficient manner and accessible while remaining in compliance with appropriate regulations and company policy.

Functional Unit: Research - Regulatory

Hiring Manager Title: Senior Research Associate

Job Requirements:
go top

Educational Qualifications Desired: 1)Serves as the regulatory Assistant GLP archivist and coordinates the compliant daily operations of the GLP archive.

a) Responsible for secure storage and archiving of critical records in support of global product registrations. May be required to modify procedures as needed with continuously changing circumstances and situations.

b) Responsible for GLP archiving of Regulatory study records, historical GLP personnel files, facility records, etc. May be required to modify procedures, including SOPs, as needed to adapt to a changing Regulatory environment.

c) Assist with the maintenance of all necessary documentation to demonstrate compliance with government regulations and company policy. May require the determination of appropriate course of action to address and participate in the development and/or modification of procedures to accommodate changing regulatory circumstances and situations.

d) Assist with the development, review and revision of archive processes and the documentation of these processes for departmental reference.

e) Coordinate record transfer to and from the long term storage facility, Pioneer research and contract research organizations [CROs].

f) Work with Quality Assurance Unit [QAU] to continually audit and improve the archive systems and routinely report findings and resolutions to the Senior GLP Archivist.

g) Maintain the archive record of laboratory reference substances.

h) Assist in maintaining the electronic data Archive system.

2) Ensure the efficient operation and maintenance of document and record management process control systems for Regulatory.

a) Processing and maintenance of study protocols, amendments, deviations and documents provided by study personnel while studies are on-going.

b) Responsible for the availability and internal distribution of controlled study documents [i.e. protocols, amendments, reports, etc.].

c) Assist in maintaining and supporting the document and record management process control systems for Regulatory while maintaining compliance with company policies and government regulations.

3) Serve as Technical Writing Support through assisting in drafting and reviewing technical reports with Regulatory scientists and managers to meet deadlines for product submissions to regulatory agencies.

a) Review protocols and amendments to ensure proper formatting.

b) Ensure final reports are compliant with PR Notice 86-5 reporting requirements.

c) Create document templates for study directors/authors to use.

d) Figure labeling.

e) Compiling figures and tables to be used in reports and protocols.

f) Reviewing and distributing draft documents for peer review

g) Provide writing and computer guidance to Regulatory staff

4) Serve as the Technical Support contact for the Wilmington regulatory electronic

document management system (DM).

a) Provide end user support and troubleshooting issues with DM functionality. Determine when to escalate to manager and/or IT Support.

b) Provide end user support documentation.

c) Schedule and perform DM end user training for users.

d) Perform DM system testing under manager supervision to verify correct functional operation of routine software releases and major upgrades.

e) Recommend changes in documentation processes, assist in the development of documentation practices and utilization of established procedures to insure information is organized in an efficient manner and accessible while remaining in compliance with appropriate regulations and company policy.

Competencies and Experience Desired: Research - Regulatory

The Scientist Careers - 4 years ago - save job
About this company
51 reviews
Join the Pioneer team and you'll become part of an organization that has continued to advance agricultural production for nearly 100 years....