Senior Strategic Medical Writer
New
A
AbbVieBiopharmaceuticals
United StatesFull-TimeSenior
SalaryUSD 96500 - 183500 / year
Apply NowOpens the employer's application page
Job Details
- Experience
- 4+ years
- Required Skills
- Project ManagementData AnalysisGCP
Requirements
- 4+ years of bio-pharmaceutical industry experience in global pharma, biotech, or life sciences.
- Bachelor's degree or higher (scientific discipline preferred).
- Comprehensive knowledge of medical and scientific terminology.
- Proficiency in writing and editing clinical and regulatory documents.
- Familiarity with ICH guidelines, GCP, and other regulatory requirements.
- Familiarity with industry standards such as CONSORT and PRISMA.
- Ability to assimilate and analyze complex data.
- Strong organizational, time management, and problem-solving skills.
- Ability to oversee multiple projects simultaneously.
- Ability to communicate complex scientific information to stakeholders.
Responsibilities
- Prepare clinical and regulatory documents for drug and device development.
- Function with autonomy while collaborating with subject matter experts.
- Coordinate the review, approval, and quality control of clinical and regulatory projects.
- Maintain document quality and compliance while meeting project timelines.
- Apply knowledge of US and international regulatory documentation guidelines.
- Participate in tactical process improvements.
- Identify and resolve issues during the writing process through escalation or direct solutions.
- Work with R&D Quality Assurance to support inspection-ready documentation.
View Full Description & ApplyYou'll be redirected to the employer's site
