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Role description:

The scientific/medical writer will be required to research, create, and edit all documents associated with clinical studies. Responsibilities also include: acting as primary client contact for medical writing projects, working with other departments and to set and meet internal / external deliverable timelines.

The desired outcomes/results of the role will be: clinical/regulatory documents (documents for clinical study conduct as well as for agencies/ authorities: study protocols and reports, investigator brochures, briefing documents, model informed consents, clinical overviews and summaries, integrated summaries of safety and efficacy, pediatric investigational plans).

Responsibilities

• Analyze, interpret and integrate data in order to provide relevant documents as agreed with clients:
• Develop and update mainly clinical but also R&D, regulatory, marketing, and other related documents such as, but not limited to: investigator brochures, protocols, clinical study reports, informed consent forms, summaries, expert reports

• Identify and anticipate information needs on scientific/clinical matters and other business-related issues:
• Clarify needs in terms of content, urgency, timing, priorities
• Keep up with relevant scientific literature and current developments and business directions within pharmaceutical industry
• Attend and contribute to relevant client meetings as applicable
• Ensure the timely delivery of relevant information and / or documents to each target audience:
• Coordinate the circulation of documents for review / approval / information
• Select the appropriate communication tool(s) in function of the information / data to disseminate, the target audience and the urgency
• Adapt information (content and format) in function of the chosen tool, audience
• Ensure and follow proper archiving, version control and security procedures of documents in compliance with "Good Documentation Practices"

Qualifications

The educational or professional qualifications the incumbent needs and is mandatory:

• Master’s degree in life sciences, ideally in Biology, Biochemistry, Pharmaceutical Sciences or Medical Sciences. (is a must)
• PhD in life sciences is a definite plus (preferable)

Key knowledge areas

The key areas of knowledge – technical or role specific – the incumbent needs:

• Excellent knowledge of the English language (Ability to write fluent and grammatically correct English is essential)
• Advanced knowledge of MS Office (Word, Excel, Power Point)
• Knowledge in immunology is preferable

Key skills:

The key skills the incumbent needs to meet the required outcomes of the role:

• Ability to work in a fast-paced environment
• Work well independently or as part of a team in high-pressure situations
• Solid writing skills, organisation and patience
• Ability to interpret and present clinical data and other complex information
• Ability to understand the purpose and requirements of the project
• Good communication & coordination with various people involved in the process
• Good time management, and meeting deadlines and commitments
• Proactive and flexible
• Excellent strategic communication skills with the ability to understand terminology, prioritize data and streamline and summarize complex concepts
• Collaborative team player
• Customer satisfaction mindset
• Problem solver
• Detail-Oriented
• Deadline-Oriented
• Organized

Experience (including length and depth of experience requirements)

The type of work experience the incumbent needs, including the length and depth of experience:

• Previous work experience as a Scientific/Medical Writer or similar role is a definite plus
• Experience in clinical trials is a definite plus
• Final stages of PhD thesis student - is accepted
• Knowledge of Food and Drug Administration (FDA) and or EU Regulations, ICH Guidelines, GCP, and/or familiarity with standard clinical operating procedures is a plus

Job offer

Remuneration and benefits

• Market competitive salary
• Food & holiday vouchers
• Private medical insurance
• Flexible work schedule
• Working from home

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