Associate Document Quality Specialist (Contractor)

Associate Document Quality Specialist (Contractor)

Position Summary

The Associate Document Quality Specialist (contractor) is responsible for performing specific document quality checking of regulatory and submission documents to ensure consistency, accuracy, and quality. This role will confirm the accuracy of data or text relative to source and ensure overall standard document development practices are followed. This position will ensure a streamlined process for these vital tasks by ensuring proper SOPs and document development processes are in place and 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.

Roles and Responsibilities

1. Performing quality control checking of documents, which includes QC of data and tables against source, document formatting, and style

2. Publishing activities including hyperlinking, bookmarking, and pagination for creation of submission ready documents

3. Working with document owners to ensure internal templates and guidelines are used for document creation

4. Interacting and collaborating with cross-functional teams

5. Confirming the submission-readiness of documents according to ICH and FDA guidelines

6. Maintaining trackers to organize and document deliverables and their current status

7. Assisting with document versioning, proper archiving, and ad hoc support for other Medical Writing activities, as needed

Requirements

Educational Requirements

• Minimum of bachelor’s degree or equivalent in scientific or medical discipline.

Professional Work Experience Requirements

• 1-4 years of experience at a pharmaceutical company or CRO is required.

Experience and Skills

• Training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry, and biotechnology

• Experience in the quality checking of regulatory submission documents

• High attention to detail, advanced writing and speaking competency, and excellent organizational skills

• Must have the ability to prioritize, manage time well, multitask, and troubleshoot

• Positive and proactive communication skills, strong interpersonal and customer service skills, and the ability to work independently

• Capable of handling assignments that are complex in nature and locating information quickly and resourcefully

• Proficiency with Adobe Acrobat and Microsoft Office Suite, and the ability to utilize additional internal software (eg, SharePoint, StartingPoint, PleaseReview, etc.)

Other Skills/Attributes

• Demonstrated alignment with Amicus Mission Focused Behaviors

• Passion for rare disease and patient-focused mindset

• Good team player who can also work independently

Location

• Preferred location is Remote (with a hybrid work approach).

Travel

• It is expected that any remote workers are able to travel to the office up to 10% of the time.

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

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