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This job was posted by https://joblink.maine.gov : For more information, please see: https://joblink.maine.gov/jobs/1194544 Beacon Hill Life Sciences has a fantastic opportunity for an experienced Regulatory Affairs CMC Technical Writer.

What you\'ll be doing:

• 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, and 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.
• Participation and facilitation of 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 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 the Client

Qualifications:

• Bachelor\'s degree with experience working in/for a pharmaceutical company
• Fluency in the understanding and format of the Common Technical Document (CTD)
• Experience with Veeva Vault RIM & Smartsheets
• Authoring experience of CTD Module 3 sections of a BLA/NDA required
• Excellent writing skills
• Proficient in MS Word

Beacon Hill is an equal opportunity employer and individuals with disabilities and/or protected veterans are encouraged to apply.

California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:

Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

Benefits Information:

Beacon Hill offers a robust benefit package including, but not limited to, medical, dental, vision, and federal and state leave programs as required by applicable agency regulations to those that meet eligibility. Upon successfully being hired, details will be provided related to our benefit offerings.

We look forward to working with you!

Beacon Hill. Employing the Future