Technical Writer CMC
Company introduction:
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments.
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways
Job 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 the 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.
Roles and responsibilities
(Include but are not limited to):
⢠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
Candidate Profile:
⢠Minimum of bachelorâs 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
ăFor NYCăCompensation Description (annually):
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.
ăBase salary per annumă:
$120,000 - $170,000 USD
Benefits & Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass".
Equal opportunities:
Reasonable accommodation
We are committed to building a workplace where everyoneâs wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.
US applicants
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 (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
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.
Data Privacy:
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
Apply Now
Apply Now
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve the lives of those who are suffering with mental health challenges and who are not helped by current treatments.
We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways
Job 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 the 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.
Roles and responsibilities
(Include but are not limited to):
⢠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
Candidate Profile:
⢠Minimum of bachelorâs 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
ăFor NYCăCompensation Description (annually):
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.
ăBase salary per annumă:
$120,000 - $170,000 USD
Benefits & Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass".
Equal opportunities:
Reasonable accommodation
We are committed to building a workplace where everyoneâs wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.
US applicants
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 (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law.
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.
Data Privacy:
All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.
Apply Now
Apply Now