Job Details

Medical Writing Contractor, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, and other key clinical and regulatory documents.

This individual will support the overall strategy for all medical writing processes according standards.

Key Accountabilities/Responsibilities:

The position will have the following key responsibilities:

• Support the clinical medical writing team, in developing content for a variety of clinical regulatory documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), safety narratives, and eCTD modules
• Draft and manage documents that are well-organized, accurate, consistent, and comply with applicable company SOPs and regulations
• Ensures all clinical documents are standardized according to the style guide and are based on company-approved document templates to ensure quality and consistency of the portfolio
• Partner with Quality Assurance (QA) during an audit of clinical trial documents to ensure timely response to findings
• Collaborate with members of clinical trial teams and other functions within medical writing to ensure project deadlines are met by providing content development support, research, and editing functions for each program

Desired Skills and Experience:

• Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred
• Native English speaker preferred
• Minimum of 5-7 years of pharmaceutical/biotechnology-related medical writing experience required
• Knowledge of all FDA and ICH guidelines for clinical reporting required
• eCTD development, publishing, and submission experience preferred
• Biologic writing experience preferred
• Basic understanding of drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission
• Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
• Ability to proofread documents for compliance with internal and external guidance documents
• Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion
• Ability to work precisely according to procedures and regulations
• Excellent written and verbal communication skills
• Ability to prioritize and multi-task successfully in a fast-paced environment
• Ability to work autonomously, as well as in a team
• Excellent time management skills and a proven ability to work on multiple projects at any given time
• Must be proficient in MS Office
• Experience in electronic publishing format preferred