Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.
Level Up @ Amicus is our Summer Internship Program, created to give students an opportunity for experiential learning in a corporate environment. This is a meaningful, mutually beneficial program where students will bring innovation and drive that will help us reach our goals. In turn, our highly-skilled Amicus team will help students apply what they already know and broaden their knowledge base.
This is a full-time (40 hours per week) paid internship that will run from May 18, 2020 until August 14, 2020. For best consideration, candidates should apply by no later than February 9, 2020.
The Medical Writing Intern will be responsible for contributing to the development of high‑quality medical writing deliverables to support one or more Amicus programs. The intern in this role will work directly on documents/projects with direct oversight.
Roles and Responsibilities
The Medical Writing Intern is responsible for:
Assisting with the annual update of three program-specific lexicons for continued use in submission documents
Contributing to the development of regulatory submission documents (eg, Developmental Safety Update Report, Investigator’s Brochure, and/or 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
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
Provide support to Medical Writing staff with department or program-related tasks, as needed
Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures, Amicus Style Guide) will be expected to perform the above functions
Developmental, Experiential & Educational Value (for Summer Intern):
The intern will gain exposure and experience in the creation of submission-ready documents according to ICH and FDA guidelines within a global regulatory setting
This position will foster an understanding of Medical Writing processes and procedures and how this function supports drug development
This position will gain exposure to a fast-paced environment
This position will introduce the intern to the management and development of regulatory documents, including, but not limited to, the planning, drafting, reviewing, and compiling of information in a clear and concise manner
The intern will gain valuable written and verbal communication skills through team collaboration, meeting facilitation, and shadowing Sr Medical Writing staff practices
Qualifications and Background Requirements
Must be a current student to apply
Bachelor of Science degree or similar with the majority of undergraduate coursework completed in the sciences (eg, biology, chemistry, biotechnology)
Preference will be given to students with >1 year of graduate education
Experience in technical written communication and a good understanding of medical terminology
This position will be based at 1 Cedar Brook Drive, Cranbury