Job Description
Job DescriptionTitle: 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.