Senior Medical Writer (US Based)
Intrinsik Health Sciences Inc. is a Canadian consulting firm focusing on the toxicology and regulatory challenges associated with the development of new products (pharmaceuticals, biologics, medical devices, consumer products, natural health products and cosmetics). In addition to our established nonclinical, chemistry, manufacturing and controls (CMC), and regulatory service areas, we are also experiencing increased demand for our medical writing services. We will always welcome candidates with strong scientific skills, creativity and enthusiasm to join our expanding team.
Intrinsik has an immediate opening for a US-based Senior Medical Writer. Our Environmental affiliate company has existing offices in Maine and California, but we are willing to be flexible in the location of medical writing staff. We aim to offer our employees a working environment that encourages professionalism, creativity, independence and continual learning. The assets of any knowledge-based company are its people, and we believe strongly in investing in those assets by offering training and mentoring of our staff. Like all successful organizations, we are committed to growing and advancing our employees’ careers by providing them with new responsibilities and opportunities within the company.
The Senior Medical Writer will be responsible for providing scientific writing expertise and developing clinical documents for the Regulatory team to generate high quality submission documents. Specifically, this position will involve writing, reviewing and editing clinical documents.
- Formulating writing strategy for key regulatory documents
- Responsible for writing, reviewing and editing clinical documents for regulatory submissions while ensuring scientific excellence and delivery within the agreed timelines
- Preparing CTD Module 2 clinical documents, investigator brochures, ISS/ISEs, clinical study reports, patient narratives, etc.
- Ensuring that the clinical documents comply with applicable national and international regulations and guidelines
The successful applicant(s) would ideally have the following qualifications:
- Minimum BSc in Life Sciences/ Health Related Sciences or equivalent; higher degree and/or medical background an asset
- Minimum 3 years of regulatory medical writing experience (MUST include hands on experience in authoring of CTD Module 2 clinical sections, ISS/ISE and clinical study reports); specific qualification in medical writing an asset
- Solid understanding of scientific principles
- Good working knowledge of national and international regulatory requirements and guidelines
- Able to analyze and interpret clinical data and summarize in a concise manner
Intrinsik is also seeking excellence in the following attributes:
- Attention to detail
- Strong organizational skills and time management
- Outstanding communication skills, both written and verbal
- Ability to work on multiple projects at the same time
- Good interpersonal skills with the ability to work well both independently and in a team
- Computer skills, particularly using MS Office and Adobe Acrobat
Interested candidates may submit their resumes via email to Andrea Kalentizis , Human Resources Manager, at