Medical Writing Editor

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Overview of Scholarrock

Scholarrock is a pioneering biopharmaceutical company that specializes in discovering, developing, and delivering innovative therapies designed to meet the needs of individuals suffering from serious diseases. These diseases often have high unmet medical needs, making Scholarrock's mission particularly significant. The company has carved out a niche in addressing conditions that have traditionally been under-researched and under-treated.

Scholarrock's focus is primarily on the transforming growth factor beta (TGFβ) superfamily of cell proteins, which play a critical role in various physiological and pathological processes. This unique position has allowed Scholarrock to lead in the development of therapies targeting areas such as neuromuscular diseases, cardiometabolic disorders, cancer, and several other critical health challenges. Scholarrock recently gained attention for being the sole company to demonstrate clinical proof of concept for a treatment targeting spinal muscular atrophy (SMA). This dedication to innovative therapies is driven by their proprietary platform which finely tunes the modulation of protein growth factors.

Position Summary

The Medical Writing Editor is a newly created role within Scholarrock that will play a crucial part in ensuring the quality and compliance of medically relevant documents. This position is fundamentally responsible for conducting in-depth quality reviews of clinical study and regulatory documents to guarantee that they meet submission readiness and compliance standards. Candidates applying for this role should possess a strong motivation for both science and writing, as well as a robust set of skills necessary to excel in the nuanced field of medical writing.

Key Responsibilities

The responsibilities of the Medical Writing Editor include, but are not limited to:

• Editing documents that support various development programs.
• Overseeing and conducting quality reviews for clinical study documents and regulatory filings, which include documents required for investigational new drug applications (IND) and biologics license applications (BLA).
• Ensuring that all documentation is clear, well-organized, accurate, and compliant with applicable standards.
• Performing copyediting tasks that focus on elements such as formatting, style guidelines, spelling, and grammar consistency.
• Conducting content quality checks (QC) in documents to ensure that they reflect an accurate interpretation of the data.
• Creating and maintaining document templates that adhere to the latest regulatory guidelines.
• Developing and updating the company’s Style Guide to maintain consistency in writing.
• Coordinating medical writing inspection readiness activities.
• Tracking QC findings and leveraging them to identify opportunities for process improvement.
• Outsourcing and managing quality control tasks as required, including training involved vendors on document quality processes.

Required Skills and Qualifications

To qualify for the Medical Writing Editor position, prospective candidates should meet the following criteria:

• A Bachelor's degree in a relevant scientific field (e.g., Biology, Chemistry, English, or Writing) is required, while an advanced degree in a relevant field is preferred.
• A minimum of 7 years of professional experience in medical writing or editing specifically within the pharmaceutical or biotech industry.
• Expert knowledge of the AMA Manual of Style and medical terminology is crucial.
• Candidates should demonstrate substantial experience in writing or editing medical documents, along with an exceptional attention to detail.
• A firm grasp of regulatory guidelines and industry standards is mandatory.
• Proficiency in various editing tools and content management systems will be expected; experience with artificial intelligence tools for medical writing is a plus.
• The capability to effectively manage tight deadlines and work autonomously while also being a team player with strong communication skills is essential.

Work Environment and Culture

Scholarrock is an Equal Opportunity Employer committed to fostering diversity and inclusion within its workforce. The company values the diverse perspectives that different backgrounds and experiences bring to the table. As a result, employee wellbeing and a supportive work environment are emphasized, creating a culture where innovation can flourish.

Conclusion

Working with Scholarrock in the role of Medical Writing Editor offers a unique opportunity to contribute to groundbreaking therapeutic advancements in the biopharmaceutical field. Candidates who share a passion for scientific communication and who possess the required expertise in Medical Writing will find this role particularly fulfilling. If you meet these qualifications and are driven by making a significant impact in the world of medicine, this position could be a great fit for you.

This job offer was originally published on remotive.com