Technical Writer CMC Job at Compass Pathways in New York

Overview

The Technical Writer, CMC will be responsible for document writing, authoring, and compiling of CMC reports and the CMC sections for regulatory (NDA) filings. This position will work closely with cross-functional teams within Quality, Clinical and Regulatory Affairs to ensure all CMC technical writing objectives are met.

Location: Hybrid in our New York City office or remote on the East Coast, USA.

Reports to: Vice-President, Manufacturing and Supply.

Responsibilities

• Author and/or review technical reports as required by CMC staff
• Author, compile, and manage CMC sections of regulatory submissions (IND/NDA)
• Effectively manage the integrated drafting and reviewing process to meet appropriate timelines
• Ensure all documents comply with regulatory guidelines, company standards, and industry best practices
• Work closely with cross-functional teams to gather input and feedback for report content and formatting
• Organize and maintain document storage to ensure easy access to reports and related documentation

Qualifications

• Minimum of bachelor’s degree in chemical, and/or biological Sciences/relevant discipline
• Over 3 years' experience in technical writing for CMC regulatory filings (especially NDA)
• Strong working knowledge of full CMC spectrum, including drug substance and drug product manufacturing, stability requirements, analytical and formulation development and GMP manufacturing considerations in general
• Knowledge of FDA, EMA and global regulations including ICH guidelines with a strong knowledge of eCTD elements and structure
• Demonstrated ability to translate technical information from mixed sources into written information suitable for regulatory authorities
• Excellent verbal/written communication skills; detail/accuracy oriented
• Proven planning and organizational skills and regulatory writing skills
• Ability to work independently in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing demands

Compensation & Benefits

Base salary: $120,000 - $170,000 USD

For an overview of our benefits package and compensation information, please visit Working at Compass.

Sponsorship & Data Privacy

Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

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Equal opportunities

Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex, ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status protected by applicable law.

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