Technical writer
Full Time • Washington,DC
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.
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.
Mission Statement
Softthink Solutions’ mission is to drive continuous innovation in IT services by prioritizing product development and implementing trustworthy computing practices. Our focus on secure and reliable product delivery is backed by sound business practices and a commitment to the long-term satisfaction of our clients in every project, regardless of its size or complexity.
Through our innovative solutions and dedicated team of experts, we strive to exceed our clients’ expectations and set the standard for excellence in the IT industry.
Vision Statement
At Softthink Solutions, our vision is to be a trusted partner for our clients, empowering them to bring their ideas to life in the most efficient and effective manner possible. We are committed to using established best practices, industry-standard processes, and cutting-edge technology to deliver top-notch solutions that exceed expectations.
Our goal is to be recognized as leaders in the industry for our innovative, reliable, and secure IT services and solutions, and to drive the success of our clients through every project we undertake.
Careers
STSI is an independent US-based Software services and consulting partner with a primary focus on long-term relationships with both clients and team members.
STSI offers team members cutting-edge technology, training, and career guidance to expand and grow their skill sets and bring maximum value to our clients.
STSI is constantly reviewing and expanding its people strength and strives to optimally match client needs to team member talents. We are a people-oriented company seeking the best and brightest to join our team. We work with a variety of employment statuses – from citizens to permanent residents to H1B and EAD immigrants. We have openings for entry level as well as senior positions across a variety of specializations with active in-house and client projects.
In an industry that’s constantly reinventing itself, STSI challenges its team members and consultants with engagements that involve specialized services and advanced IT solutions – applying agile development principles, methodical planning, creative thinking, and continuous learning. A dynamic environment keeps our team members ahead of the curve by providing:
In an industry that’s constantly reinventing itself, STSI challenges its team members and consultants with engagements that involve specialized services and advanced IT solutions – applying agile development principles, methodical planning, creative thinking, and continuous learning. A dynamic environment keeps our team members ahead of the curve by providing:
- Opportunities to work with leading multinational clients.
- A comprehensive portfolio of solutions that span leading-edge technologies from Enterprise Architecture to Business Intelligence to Quality Assurance
- Established methodologies, processes, and mentoring to maximize efficacy and efficiency.
- A growing R&D division continually exploring and pioneering the latest technological developments in a variety of disciplines.
(if you already have a resume on Indeed)