Senior Medical Writer / Assoc Director *** Remote *** Exciting Biotech company focused on CRISPR-based medicines.

Reference: SIT534A

Expiry Date: 28-02-2023

Categories Biotech, Clinical Research, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Middlesex County
United States
Remote Working

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Job Description

Location: US Fully Remote – East Coast or West Coast.

If you enjoy Medical Writing, but are now looking for a new challenge, or new modalities, for a new type of company offering flexibility and a fantastic compensation package, then send your profile to CV@AdvTalent.com and give Theo Moore or Ivan Nash a call on 587 216 9302 to discuss this role in more detail.

Our expanding Biotech and Cell & Gene Therapy client is now recruiting a Senior Medical Writer graded Associate Director, for a role where you will be independent but supported, and able to work from home and be fully remote!

From humble beginnings, to now being recognised as a star company to watch, this organisation is rapidly leading  the development of a new class of therapies for patients with genetic and oncological diseases.

As they continue their journey with a series of clever collaborations and creative input from their passionate staff, they continue to grow and  expand their early-stage development portfolio, which runs across 3 main therapy areas and includes several rare genetic diseases.

You will be joining an expanding team/group and reporting into an experienced Head of Medical Writing, who will give you the space and resources to work in the way that suits you best. The team are fully flexible around location, and lead their own projects, but offer full support as and when needed.

Role:

You will be the medical writing lead for the preparation of a variety of clinical documents including  protocols, Investigator’s Brochures, CSRs, other regulatory submission documents for clinical/regulatory purposes, including overseeing/managing medical writing vendors and coordinating the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.

You will be leading the authoring of high-quality clinical regulatory documents for early phase clinical studies/indications and developing documents for pipeline products, including pre-IND/CTA briefing documents, IND Module 2.2 Introductions and Module 2.7 Clinical Summaries, IND Module 1.20 General Investigational Plans, and regulatory responses. 

You will ensure regulatory, technical, and quality standards are achieved during document development, and relevant processes and best practices are applied, and you will contribute to development of clinical submission communication strategies for documents.

You will manage timelines and communicating with team stakeholders to maintain awareness of expectations, milestones, and deliverables and lead significant workstreams that involve working across departments or with external vendors.

 

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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