Our mission is to discover and deliver innovative medicines and solutions that address serious health issues today and anticipate the medical challenges of tomorrow. We aim to make a remarkable impact on people's lives across various key therapeutic areas - including immunology, oncology, neuroscience, and eye care - as well as through products and services in our Allergan Aesthetics portfolio.
Job Summary:
As a Principal Medical Writer, you'll play a pivotal role in providing clinical regulatory document support and advanced scientific writing expertise to our clinical teams. Your primary responsibility will be to ensure the successful preparation of high-quality submission-ready documents and the effective implementation of the writing process. You'll serve as the scientific writing content expert for our department, offering medical writing expertise across multiple compounds and projects within a therapeutic area.
Key Responsibilities:
Lead the preparation of complex clinical regulatory documents, collaborating closely with Regulatory teams to develop effective document strategies.
Compile data and information into comprehensive packages for new and updated clinical regulatory documents, ensuring accuracy and compliance with both US and international standards.
Serve as a subject matter expert within the department for assigned therapeutic/product areas, providing guidance to medical writers and ensuring the quality of work.
Convert data into formats that meet clinical regulatory document requirements and communicate effectively with target audiences.
Coordinate review meetings with the team, ensuring all necessary documentation is obtained and processed according to timelines.
Facilitate effective communication among team members, holding them accountable to project deadlines and resolving conflicts as needed.
Stay updated on US and international regulations and requirements related to clinical regulatory document preparation and submissions, advising teams on compliance issues.
Act as a department representative on project teams, providing expertise on computer-based technologies and mentoring other team members.
Qualifications:
Bachelor's degree in Science, English, or communications required, with significant relevant experience. Master's or PhD in a science discipline preferred.
Certification from organizations like the American Medical Writing Association (AMWA) preferred, with a focus on Editing/Writing or Pharmaceutical.
Minimum of 4 years of relevant industry experience in medical writing, preferably in the healthcare industry or academia.
High-level content writing experience and expertise in interpreting scientific content for different audiences.
Excellent written and oral communication skills, with superior attention to detail.
Proficiency in word processing, flow diagrams, spreadsheets, and software programs in a Windows environment.
Extensive experience working with collaborative, cross-functional teams, including project management experience.
Additional Information:
This is a remote opportunity within the US.
We offer a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and participation in short-term and long-term incentive programs.
Equal Opportunity Employer:
We are committed to diversity and inclusion in our workforce. We value and seek the unique backgrounds, experiences, and perspectives that each individual brings. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, age, sex, disability, genetic information, gender identity or expression, sexual orientation, marital status, veteran status, or any other legally protected status.
Employment Type: Full-Time
Salary: $ 93,633.00 Per Year
