Specialist, Medical Services/Writing

MSD • Upper Gwynedd Township, PA

1d • $96,200 - $151,400 • Hybrid

About The Position

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.

Requirements

• 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.
• 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

Nice To Haves

• 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)

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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level