Senior Medical Writer, New Jersey

Role posted on: 11th October 2019
G&L are a specialist provider of Regulatory Affairs resource to the healthcare industry – and we are rapidly growing! Our excellent reputation has been built on tailoring solutions and services to each of our clients, to ensure that their expectations are surpassed, and all their requirements are exceeded.
We have offices in US, Europe and Asia, working with many of the largest healthcare companies, along with a good number of SME biotech companies, university spin-offs and start-ups.
We now have an opportunity for experienced medical writers 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 time zones. Plus all our consultants 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 in their work – we work with a broad selection of pharmaceutical, biotechnology and device clients across the global, and each project can vary significantly.

Role Description: Senior Medical Writer, New Jersey

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

Criteria

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.
  • Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills
  • Strong proficiency in all MS 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

Personality Traits

Our team of consultants are expected to be ambassadors for G&L – working directly with clients and Health Authorities – so therefore 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 mentor to junior staff, contributing to the development of graduate and junior training programmes.
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!
If you would like to hear more, please send your details to talent@gandlscientific.com today!
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process. G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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