Senior Medical Writer (Contract) Job in New Jersey (NJ), Regulatory Affairs Career, Jobs in Amicus Therapeutics
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Senior Medical Writer (Contract) job in Cranbury

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Amicus Therapeutics jobs
New Jersey (NJ), Cranbury
Job Code:  399
Employer:  Amicus Therapeutics
Category:  Regulatory Affairs

Location
Country:  United States
State:  New Jersey (NJ)
City:  Cranbury
Map: 
08/28/2018

Description


Senior Medical Writer (Contract) Position Summary
Amicus Therapeutics is a biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We are looking to hire an experienced medical writing lead to be based at our headquarters in Cranbury, NJ. This Senior Medical Writer (Contract) will report to the Associate Director of Medical Writing. This individual will be responsible for providing high quality medical writing, including efficient project leadership, for one or more clinical trials. The person in this role may guide other writers (including Amicus and contract/CRO employees) and will work directly on documents/projects with cross-functional teams.
Roles and Responsibilities
- Supporting the Medical Writing Lead for one or more Amicus clinical development programs
- Within assigned projects, developing a working understanding of applicable study designs, objectives, analysis plans, and/or results
- Planning and coordination of timelines, meetings, and facilitation of cross-functional communication and contribution

- Authoring documents in a clear and accurate manner consistent with the target audience and regulatory requirements
- Analyze, interpret, and accurately present data in text, table, or figure format, as needed

- Performing document-specific tasks such as (a) Drafting or overseeing clinical study reports, (b) serving as a reviewer of statistical analysis plans and accompanying table and listing shells, (c) ensuring editorial review of documents (grammar, punctuation, and formatting), and (d) ensuring quality-checking of documents (including for submission-ready formatting)

- Provide detailed, accurate, and timely reviews of documents prepared by others, as needed
- Engaging in the use of document templates and following standard operating procedures (SOPs)
- Contributing to clinical development team meetings, with a focus on identifying and communicating any issues related to regulatory document planning, development, and approval
- Planning and conducting cross-functional meetings
- The candidate must be able to work independently and efficiently with cross functional team members. Reliance on instructions, templates, and pre-established SOPs and guidelines will be expected to perform the above functions.
ref: (399)
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