Regulatory Medical Writer
We have an opportunity for an experienced medical writer on the East Coast. Our HQ is in Warren, NJ, however, we are open to remote working so long as you are able to support East and West Coast timezones. All our consultants also need to have a flexible attitude to travel and attending client meetings.
We are looking for dynamic and flexible individuals who have a consultative approach to their work. We work with a broad selection of pharmaceutical, biotechnology and device clients across the globe and each project can vary significantly.
As part of our team, you would be acting as the medical writing lead on development programs and regulatory submission teams. Your duties may include authoring and preparing clinical and regulatory documents, including:
- Investigator’s Brochures
- Study Protocols/ Informed Consent Forms (ICF)
- General Investigational Plan
- Non-clinical Overviews (CTD section 2.4)
- Clinical Overviews (CTD Section 2.5)
- Non-clinical Summaries (CTD Section 2.6)
- Clinical Summaries (CTD Section 2.7)
- Pediatric Investigation Plans,
- Orphan Drug Designations
- Clinical Study Reports (CSR), ISS and ISE
- PSUR/ DSUR.
Our ideal candidates would have:
- A BSc degree with relevant writing experience or a BA degree with relevant scientific/medical knowledge and expertise
- A minimum of ten (10) years’ experience in medical writing
- Extensive skills in English grammar, FDA and ICH regulations and guidelines and AMA style guide
- A demonstrable, high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills
- Strong proficiency in all Microsoft products including the ability to solve technical problems with Word templates
- Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information
- A solid understanding of drug development processes, preclinical development, toxicology etc.
- Experience with effectively managing and meeting timelines/project objectives
- Expertise in multiple therapeutic areas.
Our team of consultants are expected to be ambassadors for G&L Scientific. Working directly with clients and Health Authorities we really value communication skills and the art of negotiation and diplomacy.
All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentors to junior staff, contributing to the development of graduate and junior training programs.
Above all, our company is all about our people so you should have a passion for meritocracy, recognition, and development.
We hope that you will feel excited about making suggestions or challenging existing methodologies. G&L’s reputation has been built on our customer service and client-focus – so any ideas that will help us stay ahead of the curve are encouraged.
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