Title: Technical writer Location: Washington DC Work authorization: US Citizen

Project Description: 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.

Responsibilities: Includes, but not limited to: • 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 escalate issues and risks to timelines. • Collects and shares best practices through direct communications and communities of practice.

Required Skills: • 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.

Experience/Knowledge: • 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.