Senior Medical Writer Regulatory IBs ICFs CSRs Synopsis Protocols Biostatistics

Company Description

Ergomed is a rapidly expanding full service mid-sized CRO specializing 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.

Job Description

The senior medical writer is responsible for the content, quality, and timely delivery of technical documents in support of clinical study activities (Phase I to Phase IV – PASS).

In this role, the senior medical writer will be part of a collaborative team that works with the sponsor, PM, clinical team, medical monitors, biostatistics, and potentially others in support of content creation.

The senior medical writer is responsible for (or participates in) the creation, development, review, maintenance, and oversight of all relevant technical documents while following industry best practices, regulatory standards, and internal guidelines such as SOPs.

Technical document content may include, but is not limited to: Synopsis, Protocols, Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), Clinical Study Reports (CSRs), Development Safety Update Reports (DSURs), narratives, Investigational Medicinal Product Documents (IMPD/IND/CTA/CTN), Common Technical Documents (CTD) modules, and Lay summaries.

Qualifications

• Bachelor’s degree in life sciences or other related disciplines. Master’s or Doctoral degree preferred.
• Minimum of 6 years of related experience in clinical research or technical writing, or equivalent combination of skills and education.
• Expertise in technical writing, editing, and review,
• Strong knowledge of clinical, development process, regulations.
• Strong understanding of relevant technical documents and standards,
• Strong understanding complex topics such as Oncology, Neurology, and Trial Submission standards.
  
  

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.

---