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Senior Technical Writer Contract
Posted 6 days 3 hours ago by Planet Pharma
Contract Length: 6 months
Work Arrangement: Hybrid, 2-3 days weekly on-site in Leiden
Contract Type: Freelance (Umbrella or Independent Contractor)
Our client is currently seeking a skilled Medical Writer to join their team on a contract basis. This role involves producing clear, accurate, and compliant documentation that supports various stages of drug development and healthcare projects.
Key Responsibilities
- Generate and upkeep comprehensive documents such as process narratives, technical reports, risk analyses, comparability studies, investigation reports, SOPs, and regulatory dossiers
- Liaise extensively with internal teams (CMC, Manufacturing, PD, QC, AD, QA, RA) and external partners including CROs and CDMOs to compile, verify, and harmonize technical information
- Assist in preparation and formatting of CMC documentation sections for submissions like INDs and IMPDs, as well as regulatory responses
- Adhere strictly to cGMP, GDP, and company documentation guidelines ensuring document integrity and version control within electronic management systems
- Drive continuous improvement of documentation quality by developing templates, providing training, and enforcing writing standards
Candidate Profile
- At least 7 years' experience in relevant technical writing and documentation roles
- Prior exposure to CAR-T cell therapies and lentiviral vector manufacturing highly advantageous
- Proven track record writing regulatory and scientific documents in a GMP-regulated environment
- Skilled at working collaboratively with multidisciplinary teams including Quality Control, Analytical Development, Regulatory Affairs, Quality Assurance, and more
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
Please click 'apply' or contact Finlay Keyworth (Recruiter II) at Planet Pharma for more information:
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