Medical Writer Principal
hace 4 semanas
Job Title: Principal Medical Writer
Job Summary:
We are seeking a highly skilled Principal Medical Writer to join our team at Pharmiweb. As a Principal Medical Writer, you will be responsible for developing clinical documents for submissions to regulatory authorities globally.
Key Responsibilities:
- Develop 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.
- Work directly with multidisciplinary project team members to ensure that documents meet regulatory requirements.
- Lead the submission process and be involved in writing strategic parts of submission.
Requirements:
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines strongly preferred.
- Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach.
Why Choose Us:
At 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. Because 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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