What are the responsibilities and job description for the Principal Medical Writer Job at Catalyst Clinical Research, LLC in Rockford position at Catalyst Clinical Research, LLC?
A company is looking for a Principal Medical Writer to prepare and oversee high-quality clinical documents and regulatory submissions.
Key Responsibilities :
Prepare, edit, and finalize clinical documents and regulatory submissions, integrating inputs from team membersManage the document review process and ensure project delivery from outsourced or internal sourcesCollaborate with clinical team members to interpret study results and ensure accurate representation in documents
Required Qualifications :
Bachelor's degree with 12 years, Master's degree with 7 years, or Doctoral degree with 5 years of relevant medical writing experienceProven experience writing INDs, clinical protocols, clinical study reports, and regulatory documentsThorough knowledge of clinical research concepts and regulatory guidelinesAbility to work independently and manage multiple projects under pressureStrong computer skills, including proficiency in EndNote or equivalent software
