The company is at the forefront of immunotherapy and engineered T cell therapy. They are helping change the paradigm of cancer treatment and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where they make discoveries every day – discoveries that include our own capabilities and our individual potential.
They are currently seeking to recruit highly motivated talents for different positions, to join us and be part of our exciting journey in the development of innovative cancer immunotherapies and their translation to the treatment of patients with cancer.
Description:- Responsible to prepare technical documents for global use within Operational Controls.
- 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 companies electronic document management system.
- Effectively participate on projects, escalate issues as necessary and identify/meet key milestones.
- 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 Bachelors degree.
- 5+ years’ experience in the Biopharma/Pharmaceutical industry.
- Expert in MS Office and Collaboration applications.
- Experience with electronic documentation management systems (preferable, not required).
- Project management concepts, strategies and skills.
- In depth knowledge of cGxP requirements (includes GMP, GDP, GCP, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement.
- 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.
Interested? Do not hesitate to click this apply button and get more information about this role.