Senior Clinical Document Specialist
hace 4 semanas
Job Summary
The Principal Medical Writer will be responsible for the development of clinical documents for submissions to regulatory authorities globally.
As a key member of the IAI Medical Writing Team, you will work directly with multidisciplinary project team members to write scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents.
You will be responsible for writing strategic parts of submission and leading the submission process for other team members.
Responsibilities
- Develop clinical documents for submissions to regulatory authorities globally
- Work directly with multidisciplinary project team members to write scientifically valid, complete, and consistent documents
- Write strategic parts of submission and lead the submission process for other team members
Requirements
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred)
- Extensive knowledge of English grammar with a familiarity with AMA style guide
- Understanding of FDA and ICH regulations and guidelines strongly preferred
Why Pharmiweb
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with.
When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
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