CMC Regulatory Technical Writer II

2 days ago

Reston, Virginia, United States Pyramid Consulting, Inc Full time
{"title": "CMC Regulatory Technical Writer II", "description": "Job Summary

We are seeking a highly skilled CMC Regulatory Technical Writer II to join our team at Pyramid Consulting, Inc. This is a contract opportunity with a 12+ month duration and is located in Bridgewater, NJ, and Boston, MA (hybrid schedule).

As a CMC Regulatory Technical Writer II, you will be responsible for contributing to various US, EU, and ROW dossiers, including NDA, MAA, IND, IMPD, CTA, amendments, supplements, and variations. You will define and manage the compilation of documentation, required for authoring, by reaching out to internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts, or contract manufacturing organizations (CMOs).

Key Responsibilities:

* Author CMC sections of dossiers using client templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards.
* Ensure delivery of sections in a timely manner.
* Manage the writing of responses to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts, or CMOs.
* Perform life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
* Maintain an up-to-date knowledge of client's ways of working and SOPs and develop a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.

Requirements and Technology Experience:

* Chemistry, Manufacturing and Controls (CMC) and CTD experience.
* CTD Module 3 authoring skills.
* Background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
* At least 5 years' experience in the pharmaceutical industry.
* Expertise with MS Office, Word, Excel, and document management systems such as Veeva or Documentum is a plus.
* Working knowledge of cGMP's is desired.
* Experience with CMC documentation pertinent to various dosage forms and biological product is a plus.
* Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team.
* The candidate needs very little supervision, is capable of managing their priorities independently, is highly organized, and self-motivated.
* The candidate should enjoy writing. Knowledge of US pharmaceutical Regulations is essential.
* Exposure to ex-US Regulations is desired, but not mandatory.

If you are interested in this position, please apply online for immediate consideration.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

", "requirements": "[
"Chemistry, Manufacturing and Controls (CMC) and CTD experience",
"CTD Module 3 authoring skills",
"Background of pharmaceutical manufacturing or quality control/quality assurance is a plus",
"At least 5 years' experience in the pharmaceutical industry",
"Expertise with MS Office, Word, Excel, and document management systems such as Veeva or Documentum is a plus",
"Working knowledge of cGMP's is desired",
"Experience with CMC documentation pertinent to various dosage forms and biological product is a plus",
"Excellent interpersonal communication skills are required",
"The candidate needs very little supervision",
"The candidate should enjoy writing",
"Knowledge of US pharmaceutical Regulations is essential",
"Exposure to ex-US Regulations is desired, but not mandatory"
]", "technology_experience": "[
"MS Office",
"Word",
"Excel",
"Veeva",
"Documentum",
"cGMP's"
]"}

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