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The Medical writer uses his/her scientific knowledge and writing skills to effectively and clearly communicate technical medical science information in writing. The Medical Writer will generally focus on scientific medical writing, which includes medical device studies, drug trials and regulatory documents, and marketing medical writing, which includes news releases and advertising and promotional materials for a wider audience. He/she will be responsible for ensuring compliance with all applicable regulations, i.e. drug, medical device and laboratory on a global basis.
- The major responsibilities of this person include but are not limited to the following:
- The Medical Writer will work with the Medical Director, Regulatory Affairs and Research and Development to understand the nature of the scientific work that they will be covering.
- Assesses accuracy of data, product IFUs and labels by confirming that claims are supported by and consistent with data.
- Conducts comprehensive literature searches, interprets and explains data generated from a variety of sources, including internal experiments, research documentations, charts, graphs, and tables.
- Write comprehensive clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
- The Medical Writer will compile, write, and edit medical writing deliverables covering all phases of clinical research for submission to regulatory agencies.
- Interprets data and verifies that results are consistent with protocols.
- A key task of the Medical Writer is to ensure that all deliverables are in accordance with regulations, standards, and guidelines.
Key Functions/Core Skills:
- Extensive knowledge of English grammar with a familiarity with a standard style guide.
- Ability to effectively communicate scientific or medical information in a clear and concise manner, both orally and in writing.
- Proficiency in Word, Excel, PowerPoint, email, and the Internet.
- Familiarity with the principles of medical device clinical research and EU CER requirements.
- Ability to interpret and present clinical data and other complex information.
- Experience in a Medical specialty.
- Thorough understanding of US FDA, EU MDR, and ICH regulations and guidelines.
- Experience in interpreting regulations, promotional codes or practice, guidelines and policy statements is required.
- Excellent interpersonal skills with sensitivity for a multicultural/multinational environment.
- Excellent written and oral communication skills.
- A minimum of a Master's degree is required in a a related Science Discipline, PhD or above is a plus.
- A minimum of at least 3-5 years in Medical Writing is necessary.
- Maintaining collaborative relationship with R&D, Marketing, and Operations is required.
- Maintaining collaborative relationships with external partners including regulators and external companies.
- Command of regulatory writing to include MEDDEV requirements in the EU.
- 3-5 years Medical Writing experience in the medical device or related industry.
- Strong communications and problem solving skills.
- Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
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