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 writer to be based at our headquarters in Cranbury, NJ. This Medical Writer will report to the Director of Medical Writing. This individual will be responsible for providing high quality medical writing to support for one or more clinical trials. The person in this role will work directly on documents/projects with cross-functional teams. 
Roles and Responsibilities 
Responsibilities may include but are not limited to: 

- Supporting more senior medical writers at Amicus 
- Development or updating of Investigator's Brochures, Periodic and Developmental Safety Update Reports, and related regulatory documents. 
- Incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements. 
- Review of statistical analysis plans and accompanying table and listing shells to confirm their adequacy 
- Consolidation and evaluation of review comments from colleagues to determine needed revisions 
- Proactive identification, resolution/mitigation, and/or escalation of risks or issues as needed 
- Quality-checking documents for agreement between in-text information and the source data, and for internal consistency 
- Editorial review of documents for grammar, punctuation, and submission-compliant formatting 
- As needed, preparation of or assistance with clinical study protocols and protocol amendments, clinical study reports and appendices, or other regulatory documents. 
- Operating consistent with document timelines, planning, scheduling, and conducting meetings related to your own deliverables 

- Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures, Amicus Style Guide) will be expected to perform the above functions. Additionally, you must be able to work independently and efficiently with cross-functional team members.

 

Roles and Responsibilities 
Requirements 
- Master's degree in a scientific discipline plus a minimum of 2 to 5 years industry experience. 
- Ph.D, Pharm.D, or equivalent in a scientific discipline plus a minimum of 1 to 2 years industry experience. 
- Previous experience in the writing of clinical/regulatory documents, such as protocols, investigator brochures, safety updates, and clinical study reports 
- Experience with regulatory medical writing deliverables 
- Ability to work cross-functionally with appropriate teammates to create, coordinate review of, and edit through finalization required documents in accordance with pre-established timelines 
- Ability to work in a fast-paced environment, including potential management of competing tasks 
- A good understanding of medical terminology and AMA style is needed 
- Ability to translate technical information from mixed sources into written information suitable for an audience of clinicians and regulatory authorities 
- Training in the biomedical sciences, as well as experience in technical written communication 
- Strong writing and speaking competency 
- Positive and proactive communication skills 
- Proficiency with the Microsoft Office Suite 
- Demonstrated high attention to detail Location 
- This position will be based at 1 Cedar Brook Drive, Cranbury, NJ, 08512 
- Majority of time (eg, 3 of every 5 days) are to be onsite and scheduled work-from-home days are to be scheduled around project team needs 
Travel 
- 0-5% Travel is required for this position