Oferta de trabajo: CMC Regulatory Writer

Full Time Contract Role: CMC Regulatory Writer Compensation: up to $80/hr, commensurate with experience Location: Fully Remote Length of Contract: 8 months + Position Description: Our client is looking for an experience CMC Regulatory Affairs Writer that will be working closely with the Regulatory team and reporting to the VP of Regulatory Affairs. This person will be facilitating authoring and reviews of BLAs and INDs, editing, final formatting of documents for publishing and performing data verification. Responsibilities:

• Technical writing of various regulatory submission documents related to the Chemistry, Manufacturing and Controls (CMC) for biologic pharmaceutical drug products for clinical and marketing applications including but not limited to BLAs, INDs, amendments, meeting packages, responses.

• Project management activities related to regulatory submission projects and tasks including but not limited to regulatory document writing from source technical documents, editing, facilitating reviews and tracking progress.

• Participate and facilitate meetings related to regulatory documentation and submission projects, including participation in occasional (2x/wk) early morning (8-9amET) and/or evening (5-9pmET) meetings as needed to accommodate our client's global personnel participation.

• Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites

• Writing of SOPs and Work Instructions related to regulatory affairs processes and systems

• Any other duties or activities related to regulatory affairs as assigned by Client

  Qualifications:

• Fluency in the understanding and format of the Common Technical Document (CTD).

• Authoring experience of CTD Module 3 sections of a BLA/NDA.

• Has worked in a GMP regulated environment and understanding of basic GMP concepts.

• Excellent English writing skills.

• Basic understanding of pharmaceutical manufacturing processes.

• Good communication skills.

• Proficient in MS Word.

  Education & Certifications:

• Bachelor's degree with experience working in/for a pharmaceutical company.

  Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.