Job Description

Company Description
Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient's lives.

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  Act as the study lead for multiple studies, clinical programs, and/or large/complex studies with responsibility for all medical writing related activities,
• Able to function independently for nearly all activities; only requiring support for novel, complex, or otherwise atypical activities
• Provide review and oversight to technical documents created by other members of the medical writing department
• Able to review technical and scientific documentation for unfamiliar topics to develop technical content, summarize findings, ensure scientific validity, and statement of ethical issues
• Represent the function in audits of study activity
• Represent the function in bid defences and other sales related activities
• Contribute to the overall development of the medical writing function by supporting process improvement initiatives, functional training and development activities
• Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.

In addition to the above:

• Act independently as a lead for a clinical study with responsibility for all medical writing related activities
• Develop and manage timelines, inputs, and other activities to ensure complex technical documents are developed on time and with sufficient quality (completeness/references).
• Able to review technical and scientific documentation for to develop technical content and summarize findings, represent the function in internal and external meetings for assigned studies
• Maintains responsibility for all assigned duties within a clinical study (ensuring that work is performed on time; Communicating issues and updates to the study lead in a timely manner; Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality)
• Contributes to the quality, structure, and content for technical documentation within assigned clinical studies (Reviewing all, or portions of, technical documents for clarity and grammar' Review complex documents (e.g., CSR) for correctness and consistency, verifying the presentation and interpretation of content )
• Writing all, or portions of, technical documents following client specifications, regulatory standards, and internal SoPs/guidelines

Qualifications

• 
  Bachelor's degree in life sciences or other related disciplines. Master's or Doctoral degree preferred.
• Expertise in technical writing, editing, and review - extensive experience in clinical research or technical writing, or equivalent combination of skills and education.
• Strong knowledge of clinical development process and regulations.

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  Strong understanding of relevant technical documents and standards.
• Basic understanding complex topics such as Oncology, Neurology, and Trial Submission standards.
• Advanced knowledge of English (spoken, written)

• Proficiency with the MS-Office suite; advanced knowledge of Word, Excel, and PowerPoint.

Additional Information
Why Ergomed We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer:

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application.