Medical Writer

Medical Writer
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 writer to be based at our headquarters in Cranbury, NJ. As an Amicus Medical Writer, you will focus on the preparation, assembly, writing, and review of the documentation needed to support Phase I-IV clinical development programs.
Roles and Responsibilities
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 for the evaluation and presentation of relevant clinical trial data
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.
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.
Bachelor's degree plus 5 to 7 years industry experience
Master's degree plus 2 to 5 years industry experience
Ph.D, Pharm.D, or equivalent plus 1 to 2 years industry experience
Experience and Skills
Previous experience in the writing of clinical/regulatory documents, such as protocols, investigator brochures, safety updates, and clinical study reports
Proven capacity in translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians
Training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry, and/or biotechnology
Ability to prepare deliverables in accordance with pre-established timelines, systematically performing activities in a timely and accurate manner
Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat
Understanding of medical terminology and AMA style
High attention to detail
Legally authorized to work in the United States, and not requiring, now or in the future, sponsorship for employment visa status

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