Keen Scientific is currently seeking a contract medical writer with a possibility for full-time. The writer will be responsible for clinical and regulatory writing deliverables.
– Prepares clinical study protocols, clinical study reports, Investigator’s Brochures updates, patient narratives and other clinical trial documentation
– Writes and prepares efficacy and safety summaries for NDAs
– Executes literature searches and prepares background research materials for medical information materials and medical publications (e.g. peer-reviewed journal manuscripts, congress abstracts and posters)
– Upholds lean writing principles and performs quality assurance, ensuring accuracy and scientific integrity of all deliverables
– Perform other duties as assigned
- MSc, PhD, MD, MBBS, PharmD or equivalent in a scientific/medical field
- Fluent speaker of English, with a high proficiency of written English
- At least 5 years’ experience preparing clinical study documentation, regulatory submissions or medical publications
- Academic and/or professional experience in any of the following therapeutic areas: oncology, immunology, cardiology, endocrinology, and neuroscience
- Knowledge of FDA submissions for investigational products
- Ability to analyze medical research data and review experimental protocols
- Knowledge of medical terminology, and current ICH and GCP guidelines
- Advanced proficiency in Microsoft Word, Excel and PowerPoint, document editing and referencing software applications
- High attention to detail
- High performer who can deliver on projects independently or as part of a cross-functional team
Please submit your resume along with a writing sample and three (3) professional references to email@example.com. No agencies, please.
It is the policy of Keen Scientific Services, LLC to hire, retain, promote, terminate or treat all employees, candidates and applicants without any regard to the individual’s race, color, ancestry, ethnicity, nationality, age, sexual orientation, gender, gender identity or expression, marital status, genetic information, medical condition, any medical status (including administration of any drug or biologic), physical or mental disability, protected family care or medical leave status, military or veteran status, or any other characteristic protected by federal, state and/or local laws.