Document Quality Specialist | BioNJ Talent Services

Document Quality Specialist

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics (Nasdaq:FOLD) is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

With one rare disease medicine globally commercialized for Fabry disease, an investigational enzyme replacement therapy (AT-GAA) in late stage development for the treatment of Pompe disease, and a robust gene therapy pipeline and growth platform for lysosomal storage disorders, Amicus Therapeutics is committed to changing the lives of people with these life-threatening conditions.

Job Description:

Position Summary

The Document Quality Specialist is responsible for publishing activities, performing specific document quality checking to ensure consistency, accuracy, and quality, process development for these tasks, and ensuring adherence to these processes. This role will confirm the accuracy of data or text relative to source and ensure overall standard document development practices are followed. The individual in this role will also ensure proper publishing of medical writing and regulatory documents and confirm the proper use of StartingPoint templates, and may be responsible for training others in these tasks. This position will ensure a streamlined process for these vital tasks by ensuring proper SOPs and document development processes are in place and followed.

Roles and Responsibilities

The Document Quality Specialist is responsible for:
Performing quality control checking of documents. This may include QC of data, tables, formatting, and style
Working with document owners to ensure internal templates and guidelines are used for document creation
Publishing activities including hyper-linking, bookmarking, and pagination for creation of submission-ready documents.
Confirming and quality checking of submission-ready documents according to ICH and FDA guidelines
Maintaining trackers to organize and document deliverables and their current status
Advanced writing and speaking competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, Adobe Acrobat, and high attention to detail are expected
Assisting with document versioning, proper archiving, and ad hoc support for other Medical Writing activities, as needed
Reports to the Director, Medical Writing

Qualifications: 

Requirements
Bachelor’s degree required (graduate degree preferred)
2-4 years of experience at a pharmaceutical company or CRO is required

Experience and Skills
Must have experience in the quality checking of regulatory submission documents
High attention to detail and excellent organizational skills are critical
The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology
Must have the ability to prioritize, manage time well, multitask, and troubleshoot
Positive and proactive communication skills, proficiency with Adobe Acrobat, Microsoft Office Suite, and high attention to detail are expected
Strong interpersonal, communication, and customer service skills and the ability to work independently are essential

Travel
0-5%

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other