Medical Writer - CRO/Life Science

Medical Writer - CRO/Life Science

hVIVO

Breda, Netherlands

Main Responsibilities

Responsibilities & Accountabilities:

Write and coordinate the full process of development of a document including the implementation of review comments up to finalization of the document to be written within the agreed timelines, including but not limited to:

• Clinical Trial Outline and Clinical Trial Protocol, Informed Consent Form (ICF), Amendments, Lab Manual, Clinical Study Report, Pharmacokinetic reports
• Perform quality control checks and consistency reviews of documents written by another Medical Writer, Consultant or Clinical Project Manager
• Ensure that all Medical Writing activities are performed according to the applicable guidelines and legislations (e.g. GCP, CTD, GVP) and relevant SOPs and templates
• Use Sponsor specific document management systems for review and feedback of review comments
• Communicate directly with (PK)consultant and/or Clinical Project Manager involved, as well as the counterparts at the Sponsor in order to receive the required input and to understand the exact needs of the Sponsor for the document in progress
• Attend Sponsor specific review committee meetings
• Ensure high levels of customer satisfaction by focusing on efficiency and results and exceeding customer expectations on assigned work activities

Skills & Experiences

Qualifications & Experience:

• MSc or higher-level qualifications
• At least 2-3 years’ relevant working experience within industry
• Experience in medical writing
• Experience in project management

Skills:

• Science driven mindset
• Ability to work independently and as part of a team
• Ability to find effective solutions or seek internal advice to deal with more complex matters
• Ability to be flexible and to adapt and work effectively with a variety of clients, situations or individuals
• Ability to multi-task, with skill in establishing priorities, managing workload and meeting strict deadlines
• Ability to communicate to clients and identify the needs of the clients
• Demonstrate good judgement and decision-making capability
• Good collaboration skills with ability to listen, particularly across a multicultural organisation
• Flexibility to travel and work at different locations
• Excellent written and verbal communication skills including excellent command of English

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