CMC Technical Writer (Contract, ~20-40 hours weekly)

This position is for a CMC Technical Writer who will be responsible for writing and editing technical documents in the life sciences industry. The role involves working closely with various departments to ensure written documentation is clear and compliant with CGMP and regulatory expectations. The ideal candidate should have experience in technical writing within a GMP environment, proficiency in Microsoft Word, and the ability to collaborate effectively with colleagues. Joining Vedanta Biosciences offers the opportunity to be part of a pioneering company in the development of therapies that modulate the human microbiome.

• Lead and assist in the writing and editing of technical documents such as investigations, whitepapers, protocols, technical reports, and regulatory submissions
• Tailor technical documents to the appropriate audience
• Have a clear understanding of CGMP and current regulatory expectations within the life sciences industry
• Partner with technical leadership and cross-functional partners to implement appropriate written documentation
• Integrate various sources of information into a uniform style and language for GMP and regulatory compliance
• Rewrite, clarify, or reconstruct controlled documents and investigations
• Write and edit standard operating procedures, test methods, technical/validation reports, regulatory submissions, investigations, and other related documents
• Coordinate the review, approval, and revision of procedures, specifications, and forms
• Author and review standard operating procedures, deviations, regulatory materials, training, and other controlled documents
• Provide training to others in writing/editing best practices

• Bachelor's Degree and minimum 5 years of experience in technical writing within the life sciences/GMP environment
• Minimum of 2 years' experience with quality management systems and processes
• Experience authoring and reviewing standard operating procedures, deviations, regulatory materials, training, and other controlled documents
• Advanced proficiency using Microsoft Word
• Ability to collaborate effectively; strong interpersonal skills and ability to work with colleagues that possess varying levels of writing proficiency
• Experience with training others in writing/editing best-practices

• Pioneering the development of a new class of therapies that modulate the human microbiome
• Enormous promise to treat a broad range of immune and infectious diseases
• Breakthrough discoveries in the field of mucosal immunology
• Rationally designed drug candidates in the microbiome field
• Founded by PureTech Health and a team of world-renowned experts in immunology and microbiology
• Equal employment opportunity and non-discrimination
• Reasonable accommodations for qualified individuals with disabilities
• Fully vaccinated workplace against COVID-19
• Consideration of accommodations for individuals unable to be vaccinated due to medical condition or religious objection