Associate Director, Medical Writer - REMOTE - Biologics and Cell & Gene Therapy Projects - Great Package (incl. Bonus & RSU’s)

Reference: SIT534

Expiry Date: 28-02-2023

Categories Biotech, Clinical Research, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Location:
Middlesex County
United States
Remote Working

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Job Description

Location: Fully remote (East or West Coast, US)

Exceptional package including RSU’s worth 6 figures and vesting over 3 years, with a 1/3 received each year - this package is hard to beat!

We are working with an exciting Biotech and Cell and Gene Therapy company with a unique and rather special portfolio of mixed products and modalities, across a range of high-profile therapy areas and rare diseases, mostly still in early stages of development (P1/P2).

My client is consistently voted as one of the best places to work, and have a mixed and diverse working environment, focused on inclusion and collaborative working. The culture is built around  offering new opportunities for development, training, growth, and with big(ger) plans for growth in 2023, this is a great time to be part of a company making history using CRSPR technology.

We are now looking for a Medical Writing Associate Director (or Snr Manager ready for the step up to AD), who has the capability to lead the development of key documents supporting clinical programs and regulatory submissions. In this opportunity, you will collaborate with cross-functional teams including representatives from clinical operations, regulatory affairs, medical, biostatistics, drug safety/pharmacovigilance, clinical pharmacology, translational medicine, data sciences, and program management for indications in early development (across a variety of modalities).

The role reports into a hugely experienced Head of Medical Writing, who is also super supportive and keen for his team members to always feel challenged and independent,  but always as part of group. The writing team partners with functions across the development organization, offering broad exposure to the business and providing the ability to influence and help shape the future of the organisation.

Experience:

  • Clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
  • A Bachelors, Masters, PharmD or Ph.D. in a life science or health discipline
  • A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
  • Demonstrated understanding of standard clinical document types (i.e., protocol, investigator’s brochure, clinical study reports, etc.) and experience as a lead author with such documents

The role can be fully remote, and comes with a generous package, including a strong basic, competitive bonus and exceptional LTi scheme in the form of RSU’s which is 6 figures and vests over 3 years, with a 1/3 received each year (this package is hard to beat!).

 

To Apply!

To apply for this role or if you are considering making a move into Cell and Gene Therapy, please contact me, Theo Moore on US 587 216 9302 or my colleague Ivan Nash on US 908 378 8980 or send a full CV to Ivan.Nash@AdvTalent.com and we will reply by return. We will support you throughout the interview and on-boarding experience.

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