Medical Writer (Contract) | BioNJ Talent Services

Medical Writer (Contract)

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

COMPANY PROFILE
We are passionate about what we do
Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

POSITION SUMMARY
The Medical Writer (Contract) will focus on the preparation, assembly, writing, and review of the analyses and documentation needed in support of clinical programs and trials and corresponding submissions to regulatory authorities. The person in the contract position of Medical Writer (cMW) will be responsible for the expanded development, implementation, and maintenance of operations related to Amicus clinical trial registration and results disclosure. This cMW will also provide cross-program support for upcoming submissions, supporting existing Senior Medical Writers. The cMW will manage and perform Amicus clinical study results posting activities to global external databases, websites, or similar platforms. The cMW will ensure Amicus compliance with global regulations regarding clinical study results disclosure, including potentially performing or managing document redaction.

ROLES AND RESPONSIBILITIES
Development, implementation, and maintenance of operations related to Amicus clinical trial results disclosure throughout each product’s development lifecycle
Provide overall medical writing support for ongoing programs. Preparation of clinical study-related documents, such as protocols, protocol amendments, clinical study reports, or other regulatory documents supporting ongoing clinical development programs
Direct performance of authoring for clinical trial results disclosure on ClinicalTrials.gov or similar platforms, including initial drafting, collaborative review and revision, quality control activities, approval, and release/publication for public disclosure
Proactive management of project timelines, ensuring that all relevant timelines are communicated, working cross-functionally, meeting required deadlines, maintenance of document archives, and updating project tracking systems
Quality-checking documents for agreement between in-text information and the source data, and for internal consistency
Redaction for study conduct and regulatory submissions. Responsible for managing document redaction and other activities associated with data transparency
Responsible for ensuring that Amicus clinical trial disclosure is in compliance with applicable global regulations. Ongoingly develops and shares expert knowledge of regulations, requirements, policies, and guidelines that apply to the clinical trial registration and results disclosure. Involves continually monitoring the external environment for changes to applicable regulations and standards, liaising with legal and regulatory departments on the interpretation of new laws or regulations, and assessing new laws or regulations for their effect on Amicus disclosure processes.
Responsible for building and maintaining collaborative relationships with medical writing and global regulatory affairs partners, including CROs or other vendors

Qualifications: 

REQUIREMENTS
Bachelor’s degree in a scientific discipline plus a minimum of 5-7 years industry experience.
Master’s degree in a scientific discipline plus a minimum of 2-5 years industry experience.
Ph.D, Pharm.D, or equivalent in a scientific discipline plus a minimum of 1-2 years industry experience.
Previous experience at a pharmaceutical or Clinical CRO company is required.
EXPERIENCE AND SKILLS
This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians. It will be essential to approach issues from a number of perspectives, summarizing data to draw a conclusion.
The applicant would have previous experience in the writing and development of clinical trial results postings. This person must work cross-functionally with appropriate teammates to create results postings, coordinate their review, and edit through finalization.
The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication.
Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat are needed.
Applicant must be able to prepare deliverables in accordance with pre-established timelines, systematically performing activities in a timely and accurate manner.
High attention to detail and the ability to work independently are essential.
Excellent understanding of clinical trial disclosure and transparency requirements and how they relate to the clinical development process, from protocol generation to final dossier delivery.
The applicant must have experience with document redaction.
The applicant is desired to have experience in writing and reviewing standard operating procedures.
A good understanding of medical terminology and AMA style is needed.
TRAVEL
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Additional Job or Internship Information
Position Type: 
Contract
Function: 
Medical
Paid: 
Yes