Specialist, Medical Services/Writing

Job Description

Within the dynamic environment of Nonclinical Drug Safety (NDS), a Specialist in Information Management works with internal scientific staff and across our Research & Development Division to coordinate, assemble, and manage regulatory documents for internal studies and those acquired from external efforts.   Using document management, publishing, and other tools, the Specialist will support Preclinical Development (PCD) end user operations in Veeva and development of internal processes and tools to optimize document functions.  The specialist will also participate in the design, development, operationalization & rollout and/or support of automation capabilities supporting document generation and management in PCD.

Responsibilities:

• Constructing, supporting, and managing regulatory documents and components.

• Active participation in use, support, and implementation of document management systems, tools, and automation capabilities that enable effective and compliant document management in PCD.

• Careful collaboration with internal and external stakeholders.

• Quality review to ensure that regulatory documents are appropriate, complete and consistent with regulatory expectations.

Minimum qualifications required:

• BS/BA degree including degrees in biological, chemical, computer science, and/or medical science disciplines a minimum 3 years direct and relevant experience (OR)

• MS/MA, including degrees in biological, chemical, computer science, and/or medical science disciplines a minimum 2 years direct and relevant experience.

Required experience and skills:

• Experience with nonclinical drug development

• Significant experience with Microsoft Office Suite and related computer systems tools

• Significant attention to detail and quality attributes

• Solid command of English grammar, and robust editing & proofreading skills.

• Strong candidates will demonstrate good leadership skills as well as the ability to work and communicate effectively

Preferred experience & education:

• Direct, advanced experience with Veeva Vault operations and functions (e.g. super / advanced user, system owner, or equivalent); experience including process design / development, generation of procedural controls, and/or end-user support desired.

• Experience with report automation (technical design, development, operation, implementation)

• Experience with publishing tools

• Have a solid understanding of applicable GxP regulations (highly preferred)

Required Skills:

Change Catalyst, Change Catalyst, Compliance Implementation, Compliance Remediation, Computer Science, Detail-Oriented, Document Management, Drug Development, Electronic Document Management System (EDMS), Good Laboratory Practices (GLPs), Information Management, Information Systems Management, Internal Processes, Literature Development, Microsoft Office, Policy Interpretation, Proper Grammar, Publishing, Regulatory Documents, Regulatory Reporting, Regulatory Submissions, Regulatory Training, Report Automation, Reviewing Literature, Standard Operating Procedure (SOP) {+ 2 more}

Preferred Skills:

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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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