Technical writer

Title:

Technical writer

Location:

Washington DC

Work authorization: US Citizen

The technical writer positions are responsible to prepare technical documents for global use within Operational Controls including:
Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution, and Governance Controls:
Management Responsibilities, Training & Qualification, Event Management, Document & Change Management, Quality Risk Management.

• Document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
• Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.
• Support Global Product Development & Supply organization for the Client's electronic document management system.
• Synthesize feedback from SMEs/procedural document teams to identify and resolve issues to accurately document current and future processes.
• Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans.
• Effectively participate on projects, escalate issues as necessary and identify/meet key milestones.
• Work with limited guidance to manage the development of global procedural documents and, seek input as needed.
• Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies.
• Ability to identify, manage, and/or elevate issues and risks to timelines.
• Collects and shares best practices through direct communications and communities of practice.

• Minimum of a bachelor's degree.
• 5+ years' experience in the Biopharm/Pharmaceutical industry.
• Expertise in Microsoft Suite; specifically, Word.
• Ability to communicate with all levels of leadership/management.
• Pharm/Bio Tech regulated Background.
• Ability to collaborate to drive solutions.
• Excellent technical writing skills.
• Expert in MS Office and Collaboration applications.
• Experience with electronic documentation management systems (preferable, not required).
• Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
• Strong verbal and written communication skills.
• Project management concepts, strategies and skills.
• Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures.

• In-depth knowledge of cGxP requirements (includes GMP, GDP, Google Cloud Platform, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement.
• Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations.
• Strong negotiating and influencing skills in a matrixed organization.
• Ability to drive consensus, performance and to lead strategically.
• High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas.
• Ability to participate on teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner.
• Demonstrated ability to work independently.