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AbbVie is a prominent company in the bio-pharmaceutical industry focused on discovering and delivering innovative medications and solutions that address significant health issues. The company aims to positively impact people's lives through several key therapeutic areas, including immunology, oncology, neuroscience, and eye care. AbbVie also has a portfolio of products and services in Allergan Aesthetics. For more information on AbbVie’s mission and initiatives, interested applicants can explore the company’s website.
The role of the Principal Strategic Medical Writer at AbbVie is essential for leading and writing clinical and regulatory documents that support the company’s objectives. This position focuses heavily on the independent writing of clinical and regulatory documents, as well as the management of the review process involving multiple functions to ensure the accuracy and quality of the documents produced.
As a Principal Strategic Medical Writer, the responsibilities extend beyond writing. Key tasks include:
Independently Writing Clinical and Regulatory Documents: Taking ownership of creating most clinical and regulatory documents.
Coordination: Managing the review, approval, and quality control processes by gathering input from various teams and ensuring all necessary parties are involved.
Review Meetings: Organizing and leading review meetings to guarantee comprehensive evaluation of content provided in the documents.
Team Collaboration: Working closely with teams to develop document authoring strategies and ensure that project goals are met seamlessly.
Project Management: Contributing to project management strategies, leading teams, and driving towards submission objectives, which helps streamline the pathway to effective document submissions.
Regulatory Knowledge: Gaining expertise in US and international regulations, which is crucial for drafting regulatory documentation.
Problem-solving: Identifying and proposing solutions throughout the writing process, ensuring any queries or issues are resolved promptly.
Consultation with R&D: Working independently with the R&D Quality Assurance team to address inquiries and maintain a state of operational readiness for inspections.
To be eligible for this position, applicants must meet certain qualifications:
Experience: A minimum of 5+ years of experience in the bio-pharmaceutical industry, particularly in global pharma, biotech, or life sciences.
Educational Background: A Bachelor’s Degree or higher in a scientific discipline is required.
Communication Skills: Outstanding written and oral communication abilities, with a deep understanding of medical and scientific terminology across different therapeutic areas.
Data Proficiency: Proficient in analyzing and assimilating complex data, as well as extensive experience in writing and editing clinical documents per guidelines like ICH, GCP, and other regulatory prerequisites.
Industry Knowledge: Familiarity with industry standards, such as CONSORT and PRISMA, is crucial.
Understanding of Drug Development: An advanced comprehension of drug development processes, clinical research methodologies, and biostatistics will be necessary to navigate discussions with teams and stakeholders effectively.
Organizational Skills: Strong organizational, time management, and problem-solving skills to oversee multiple projects concurrently.
Though specific salary details are not provided, AbbVie offers a comprehensive benefits package that includes:
Paid time off for vacations, holidays, and sick days.
Medical, dental, and vision insurance.
401(k) plan options for eligible employees.
Participation in short-term and long-term incentive programs.
It is also noted that compensation may vary depending on various factors, including geographic location and the responsibilities associated with this position.
AbbVie emphasizes the importance of diversity, equity, and inclusion in the workplace, reinforcing its commitment to treating all employees equally regardless of their backgrounds. They proudly support programs and initiatives aimed at fairness and innovation in health care.
AbbVie is an equal opportunity employer. Applicants based in the US and Puerto Rico are given the opportunity for reasonable accommodations during the hiring process.
For job seekers looking to apply for the Principal Strategic Medical Writer position at AbbVie, emphasis should be placed on demonstrated experience in the bio-pharmaceutical field, strong communication skillset, and a thorough understanding of regulatory requirements surrounding clinical documentation. This position offers an excellent opportunity for those looking to advance their careers within a reputable company dedicated to improving health outcomes.
This job offer was originally published on remotive.com
This job offer summary has been generated using automated technology. While we strive for accuracy, it may not always fully capture the nuances and details of the original job posting. We recommend reviewing the complete job listing before making any decisions or applications.
