Principal Strategic Medical Writer (Remote)

BioSpace; Irvine (CA); Remote; USD 90,000 - 150,000; Full time

Job summary

An innovative firm is seeking a Principal Strategic Medical Writer to lead the creation of clinical and regulatory documents. This role is pivotal in ensuring that all written materials align with project goals and regulatory requirements. The ideal candidate will have extensive experience in the bio-pharmaceutical industry, showcasing exceptional communication skills and a strong understanding of medical terminology. Join a team dedicated to making a significant impact on health solutions and enjoy the flexibility of a remote position while contributing to groundbreaking projects in the medical field.

Qualifications

• 5+ years of experience in the bio-pharmaceutical industry.
• Outstanding communication skills with knowledge of medical terminology.

Responsibilities

• Lead and write clinical and regulatory documents.
• Coordinate review and approval processes with other functions.
• Implement process improvements to enhance efficiency.

Skills

Written Communication

Oral Communication

Data Analysis

Regulatory Knowledge

Organizational Skills

Problem Solving

Education

Bachelor's Degree in a Scientific Discipline

Job description

Principal Strategic Medical Writer (Remote)

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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn, and TikTok.

Job Description

The Principal Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents that support the company's objectives.

Responsibilities

• Independently write most clinical and regulatory documents within their remit.
• Coordinate review, approval, and quality control processes involving other functions.
• Arrange and conduct review meetings to ensure thorough content examination.
• Work closely with teams on document authoring and content strategies to align with project goals.
• Communicate deliverables, processes, and timelines clearly to team members.
• Hold team members accountable for project deadlines, contributing to timely submissions.
• Contribute to project management strategies and lead team members towards submission goals.
• Recommend and implement process improvements to enhance efficiency.
• Develop expertise in US and international regulations related to regulatory documentation.
• Identify and propose solutions to issues that arise during writing, escalating as needed.
• Apply therapeutic area and product knowledge to scientific projects and business initiatives.
• Collaborate with R&D Quality Assurance to address inquiries and draft responses, maintaining inspection readiness.

Qualifications

• Minimum of 5+ years of bio-pharmaceutical industry experience across therapeutic areas.
• Bachelor's Degree or higher in a scientific discipline.
• Outstanding written and oral communication skills, with knowledge of medical/scientific terminology.
• Proficient in analyzing complex data and writing/editing clinical documents following guidelines (ICH, GCP, etc.).
• Knowledge of drug development, clinical research, study designs, biostatistics, pharmacology, and regulatory requirements.
• Strong organizational, time management, and problem-solving skills.

Additional Information

Details about compensation, benefits, and equal opportunity employment are included, with links for reasonable accommodations and further information.