Vacancy expired!
TECHNICAL WRITERNEW BRUNSWICK, NJ Candidate will be remote until COVID restrictions lifted. 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.
- 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.
Vacancy expired!