CMC Technical Writer (Contract-to-Perm)

Title:                    CMC Technical Writer (Contract-to-Perm)

Location:            Cambridge, MA

Reports to:         Director, CMC Operations & Strategic Planning

The Role:

This position will lead and assist in the writing and editing of technical documents such as investigations, whitepapers, protocols, technical reports, and regulatory submissions to make these documents as clear as possible and tailor them to the appropriate audience. The individual must have a clear understanding of CGMP and current regulatory expectations within the life sciences industry.

Here’s What You’ll Do:

• Partner with technical leadership and cross-functional partners such as Manufacturing, Quality, Process Development, Validation, and Facilities to implement appropriate written documentation.
• Integrate various sources of information into a uniform style and language for GMP and regulatory compliance.
• Work with initiators to 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.

Requirements:

• 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.

Why join Vedanta Biosciences

Vedanta is pioneering the development of a new class of therapies that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field. Vedanta was founded by PureTech Health and a team of world-renowned experts in immunology and microbiology. 

We invite you to explore our site to learn more about our company and how our discovery platform enables identification of bacterial consortia with drug-like properties and their manufacture to GMP standards.

Vedanta is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vedanta will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Vedanta Biosciences requires all employees to be fully vaccinated against COVID-19 and newly hired employees must be fully vaccinated prior to their employment start date. Vedanta Biosciences will consider accommodations for individuals who are unable to be vaccinated against COVID-19 due to a qualifying medical condition or disability or a sincerely held religious objection.