CMC Technical Writer

Orchard Therapeutics (www.orchard-tx.com), is global, fully integrated biotech company. Orchard's mission is to transform the lives of patients with rare diseases through innovative gene therapies. The company is developing ex-vivo autologous hematopoietic stem cell gene therapy to restore normal gene function in primary immune deficiencies, metabolic diseases, and hematological disorders.

We are seeking an experienced CMC technical writer to prepare and draft CMC content for global regulatory filings such as Investigational New Drug (IND) Applications, Investigative Medicinal Product Dossiers (IMPD), Biologics License Applications (BLA), Marketing Authorization Applications (MAA) and CMC sections of Health Authority Meeting Briefing Books. The technical writer will work in close collaboration with the Regulatory CMC lead and will liaise with key CMC functions, draft needed regulatory content, and collaborate in cross-functional team reviews of the drafted documents.

Requirements

Required knowledge

• Extensive knowledge of eCTD structure and subsections, including appendices.
• Minimum 3 years working in the pharmaceutical industry, preferably in a biotechnology company, with emphasis on writing and drafting CMC regulatory content.
• Experience in biologics and/or cell and gene therapy is preferred.
• Experience in authoring documents for regulatory (FDA, EMA) review.
• Proficiency in evaluating data, reviewing and summarizing technical reports into regulatory documents and leading cross-functional CMC team members in adjudicating management review comments on regulatory draft documents per project plan timelines.
• Understanding of regulatory CMC requirements outlined in FDA, EMA and ICH regulations and guidelines.

Skills & Abilities

• The candidate should have excellent writing skills and should be an excellent communicator.
• A highly motivated team player with demonstrated ability to work with technical personnel of different backgrounds.

Education

• Bachelor's degree in biological sciences, bioengineering, chemical engineering, analytical sciences, or a related field. Master's degree a plus. Technical/Medical writing credentials desirable.