Senior Medical Writer
Senior Medical Writer
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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) Investigators 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 :
- Bachelors degree in life sciences or other related disciplines. Masters 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 humancentric 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.
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
