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The Spear Group Full-Time Opportunity w/ Benefits

Position: Technical Writer – Pharma Manufacturing

Location: Harrisonburg, VA Area

Position Summary:

The Spear Group has an exciting opportunity for a technical writer in the pharmaceutical industry. We are seeking an experienced technical writer who is detail oriented, organized and possesses strong writing skills. This role will work closely with cross-functional technical and business project teams to define needs and support document update projects. The ideal candidate will have a bachelor’s degree and have well-developed writing skills to support our top-tier pharma client with tech writing and documentation tasks crucial to maintaining the data integrity of the organization. The technical writing support is mainly for the pharmaceutical manufacturing processing areas, but this position sits in company sitewide documentation / technical writing internal customer service department and will support all internal pharma business areas, not restricted to the pharma processing area. Experience writing in a regulated business environment like manufacturing / cGMP is required.

Key Responsibilities:

• Work closely with cross-functional technical and business project teams to define needs and support document update projects and deployment for assigned process areas.
• Coordinate procedure updates relating to regulatory commitments, data compliance practices, right-first-time (RFT) concerns, CAPAs (Corrective And Preventive Actions), and site projects.
• Manage and escalate timing issues related to documentation implementation.
• Review and author documentation updates for compliance with standard document content and procedures.
• Serve as author and liaison between shop floor, technical operations, quality, and site support teams for documentation excellence and compliance with cGMPs.
• Collaborate with site learning and development team for procedural updates and practices.
• Coordinate the needs of functional areas and establish priorities for documentation enhancements such as implementing new functionality, converting to electronic forms and data recording, and compliance with templates for new and revised procedures.
• Act as a gatekeeper for document updates within areas of responsibility.
• Assist with technical support and training sessions for employees for documentation related changes and improvements.
• Maintain knowledge relating to core internal procedures and applicable regulations (domestic and international). Review regulatory citations and other pertinent information.
• Participate on teams supporting internal functions and/or evaluating area procedures for improvement opportunities.
• Complete other duties as assigned by the document resources manager.

Required Experience and Education:

• Minimum Education Requirement: Bachelor’s Degree or higher - Preferred Education: Major or minor in technical writing, English, and/or science field such as biochemistry, biology, chemistry, chemical or biochemical engineering, integrated science, or related fields of study
• A minimum of 2 years in a regulated industry or environment
• Demonstrated self-starter with capability to develop innovative solutions to challenges
• Demonstrated leadership skills and ability to lead cross-functional project teams to deliver results
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
• Excellent written and oral communication skills (must complete a technical writing assessment)
• Experience with Microsoft Office, particularly Word and Excel
• Ability to prioritize, manage multiple tasks, and meet deadlines
• Ability to organize and maintain data or information
• Ability to learn through observation and hands on experience
• Technical Writing Experience
• A plus if experienced using EDMS (Electronic Document Management System). Veeva Vault and MEDS is used in conjunction with MSOffice.

Compensation based of relevant experience

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.