Proclinical is seeking a remote Manager ICF Medical Writing – Writing Informed Consent Forms – Large Pharma for a leading biopharmaceutical company. In this position, you will prepare informed consent forms (ICFs) in support of clinical trials, as well as work with cross– functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Global Patient Safety, and Clinical Data Science) to deliver documents on time and per team expectations and drive document strategy for Medical Writing.
Must be eligible to work in the US.
- Author ICFs according to regulatory requirements and Company internal document standards.
- May participate on cross functional teams, providing guidance for optimal presentation to achieve document intent.
- Manage document timeline and resource planning with input from a more senior medical writer.
- Manage contractors to ensure the highest quality of medical writing and adherence to Company document standards.
- Participates in development/improvement of document standards, templates, and processes and other non– medical writing activities.
Skills And Requirements
- The ability to understand the needs of a team and manage their expectations and use various communication styles to work effectively with teams.
- The ability to balance integrity and efficiency when managing attention to detail.
- Knowledge of informed consent requirements/guidelines and health literacy principles.
- Proficiency in the use of Microsoft Office and document management systems.
- Bachelor’s degree, or local equivalent, or relevant experience.
- Relevant experience includes clinical research and development, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.
If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929– 388– 1650 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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