Associate Medical Writer/QC Specialist

Position Summary

We are seeking a detail-oriented Associate Medical Writer/QC Specialist to support the development of our clinical trial documents and regulatory submissions. 

The ideal candidate will demonstrate writing experience and full quality control capabilities in developing clinical study reports, protocols, Investigator’s Brochures, DSUSRs and related documents. This role focuses on scientific writing and meticulous document compilation. 

The successful candidate will optimize SharePoint document organization, work efficiently under shortened deadlines, and proactively communicate with stakeholders to ensure adherence to established timelines. 

Additional responsibilities may be assigned depending on project needs and organizational priorities.

Location: Remote or Warren, New Jersey (hybrid 3 days a week if local)

Roles and Responsibilities:

• Support the development of clinical documents that are compliant with regulatory guidelines including preparation of redlined versions and summary of changes documents as required
• Perform comprehensive quality control (QC) reviews of deliverables including editorial, formatting, verification against source documents, and cross-referencing data consistency
• Develop and maintain document components such as lists of abbreviations and references, appendices, and ensure consistent formatting and style throughout documents
• Format documents (i.e., tables, figures, cross-reference insertions)
• Effectively incorporate reviewer’s feedback and lead comment adjudication meetings
• Summarize statistical outputs into clear, regulatory-compliant narrative text
• Adhere to timelines for each document and provide status updates to management as requested

Qualifications

• Bachelor’s degree in life sciences, scientific communications or related field.
• Minimum 2+ years of medical writing and QC experience is required
• Strong attention to detail with proven QC experience
• Strong multi-tasking skills and proven ability to meet tight deadlines
• Proficient in Microsoft Office suite, reference databases, and SharePoint
• Proficient in summarizing data from Tables, Figures, and Listings (TFLs)
• Excellent computer literacy and written communication skills
• Good understanding of the drug development process
• Familiarity with ICH-GCP guidelines, and regulatory submission requirements (FDA, EMA)

Preferred Qualifications

• Advanced degree
• Ability to interpret and organize complex scientific content into concise messages
• GCP or AMWA Certification

Behavorial Skills

• Curiosity: Keep on exploring uncharted territories. Always ask “why?” and more importantly “why not?”,
• Courage: Take smart risks, mentor each other to always do better & be accountable for our choices, our opinions, and our actions,
• Collaboration: Teamwork and spirit. Support each other and be equally involved in the achievement of our common goals,
• Credibility: Be transparent, follow through and build trust. Educate ourselves about our unique technology

The typical compensation range for this role is $85,000 to $101,000 per annum depending on experience, plus full benefits including but not limited to: annual bonus, 15 vacation days, health, dental and optical insurance, plus much more!