Our client is a Biopharmaceutical company in the Amsterdam area. Their focus is on immunotherapy, especially in CAR-T cell therapy. Do you want to be part of their mission of curing cancer?
The technical writer is 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.
* 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 in order 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 BSc degree.
* 5+ years' experience in the Biopharma/Pharmaceutical industry.
* 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 in English and preferably Dutch.
* 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, GCP, 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.
* Temporary project for a minimum of 3 months with possible extension.
* Start asap.
* An attractive compensation package.
* Office-based, remotely or a combination.
Please contact Hajar Amagir via +31 6 26326600 for more information or apply directly!
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