Brief Job Description:
Draft and perform quality check of technical documents (supporting documents, protocols, protocol
amendments, reports, standard operating procedures, dossiers, position papers, templates, and SIPs) for
formats, styles, compatibility, etc. as appropriate ...
Correspond with contract research organizations (CROs), FMC study monitors and product technical
experts (PTEs), or country regulatory managers (CRMs) to confirm and resolve document issues and
guideline discrepancies and external suppliers
Create electronic document versions (Word, PDF, etc.)
Import documents into Veeva Regulatory One following all appropriate document management rules
Define metadata (properties) for each document and align according to database standards
Preform advanced searches in Veeva RegulatoryOne
Maintain templates based on current standards and guidelines
Education/Role Qualifications & Years of Experience:
Master’s degree in science, biology, chemistry, or equivalence in experience
1-5 years of experience managing technical documents.
Strong computer and MS office skills, particularly Word (styles and format) and PDF.
Should possess SharePoint knowledge
Must possess some understanding technical documents
Understanding of content management file structure
Must be fluent in English (both oral and written) with ability to express ideas and thoughts effectively to
supervisor, technical experts, and peers.
Organized, detail oriented, work independently
Comfortable working with people from different countries and cultures.
Team player, networking and interpersonal skills are necessary
Able to follow established business rules, processes, and structure
Ability to work under deadline pressure
Must show abilities to proactively resolve conflict and issues to ensure business continuity
experience
3show more Brief Job Description:
Draft and perform quality check of technical documents (supporting documents, protocols, protocol
amendments, reports, standard operating procedures, dossiers, position papers, templates, and SIPs) for
formats, styles, compatibility, etc. as appropriate
Correspond with contract research organizations (CROs), FMC study monitors and product technical
experts (PTEs), or country regulatory managers (CRMs) to confirm and resolve document issues and
guideline discrepancies and external suppliers
Create electronic document versions (Word, PDF, etc.)
Import documents into Veeva Regulatory One following all appropriate document management rules
Define metadata (properties) for each document and align according to database standards
Preform advanced searches in Veeva RegulatoryOne
Maintain templates based on current standards and guidelines
Education/Role Qualifications & Years of Experience:
Master’s degree in science, biology, chemistry, or equivalence in experience
1-5 years of experience managing technical documents. ...
Strong computer and MS office skills, particularly Word (styles and format) and PDF.
Should possess SharePoint knowledge
Must possess some understanding technical documents
Understanding of content management file structure
Must be fluent in English (both oral and written) with ability to express ideas and thoughts effectively to
supervisor, technical experts, and peers.
Organized, detail oriented, work independently
Comfortable working with people from different countries and cultures.
Team player, networking and interpersonal skills are necessary
Able to follow established business rules, processes, and structure
Ability to work under deadline pressure
Must show abilities to proactively resolve conflict and issues to ensure business continuity
experience
3show more
