This role is full time, permanent and home based in any region (US).
SUMMARY: The Medical Writer carries out regulatory and medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget and to the highest possible written, scientific, and ethical standards in accordance with International Conference on Harmonisation (ICH) guidelines and WCT standard operating procedures.
Tasks may include but are not limited to:
– Preparation of clinical study reports (CSRs) and integrated summaries of efficacy and safety for a wide variety of therapeutic indications.
– Assistance in the preparation and review of study protocols and study protocol synopses.
– Assistance in the preparation of study feasibility questionnaires, as well as related reports under the purview of Medical & Scientific Affairs.
– Production of manuscripts or other print-related media for submission to journals or used in other sponsor-related medical/professional activities as requested and contracted by sponsors.
– Attendance at client meetings and participation in multidisciplinary teams.
– Production of high quality documents in compliance with ICH requirements and WCT standard operating procedures.
– Advising and mentoring colleagues and clients on medical writing-related issues.
– Perform other duties as assigned
The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
OTHER SKILLS AND ABILITIES:
– Excellent written English, able to accurately interpret data and express findings in a clear and concise written manner.
– Excellent project/time management and organizational skills and ability to work on own initiative.
– Flexibility in meeting challenging deadlines and changing requirements.
– Comprehensive Microsoft Office, especially WORD but also PowerPoint and Excel, skills and internet skills.
– Knowledge and experience in internet research.
– Ability to communicate with professionals from a variety of backgrounds.
– Attention to detail–style, consistency, grammar, syntax, scientific accuracy.
– Good interpersonal skills with confidence in managing clients/authors.
– Life-science graduate with a minimum of 3 years’ previous medical writing experience in a clinical trials environment.
– Member in good standing of the American or European Medical Writers Association.
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. # L1-HD1