Regulatory/Technical Writer | Emerging Biotech | FDA Application/Approvals:
Regulatory/Technical Writer | Emerging Biotech | FDA Application/Approvals
We have an incredible opportunity for an experienced Technical/Regulatory Writer for our client based in Lowell who is on the front-lines of creating a COVID-19 test that will providepractically instantaneous and extremely accurate results. This company is emerging with an entire platform of products beyond C-19, which makes this an incredible, longterm opportunity with someone that can hit the ground running with FDA applications, approvals, post-approval and grants/funding technical writing experience! This is a full-time, permanent salaried plus benefits role. We are only considering local candidates at this time.
- The candidate must have excellent Chemistry, Manufacturing and Controls (CMC) technical writing and communication skills with a strong background in pharmaceutical or biotech manufacturing, regulatory writing or quality control/quality assurance with at least 5-7years' experience in pharmaceutical/biotechmanufacturing or development.
- Expertise with MS Office and working knowledge of cGMP's is required.
- Product development, process validation and experience with CMC documentation are necessary.
- A BS/BA degree in Pharmacy, Chemistry, Biology or science is required, advanced degree preferred (MS/PhD).
- This position requires the incumbent to be highly organized, self-motivated, and able to juggle multiple priorities.
- The desired candidate will have the capacity to be productive with very little supervision and enjoy writing.
- Excellent interpersonal communication skills are required. Knowledge of the US regulatory processes is necessary and exposure to non-US regulatory activities is desired.
- The candidate must have prior experience writing CMC technical reports or CMC regulatory content or Quality Investigations with a demonstrated ability to interact with a multi-disciplined team.
- Experience with standardized templates and familiarity with US and International regulatory submissions is desired.
- The ability to communicate using oral and written skills with an excellent knowledge of the English language and strong proofreading and spelling skills is required.
- Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDAproducts in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF annual updates for assigned products in eCTD format.
- Work closely with technical staff and with external contractors to communicate, coordinate and track required documentation in support of new and post-approval CMC regulatory activities.
- Contribute to various projects by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations.
- Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports.
- Recommend table of contents for regulatory submissions.
- Develop and contribute to regulatory strategy for successful product registration.
- Provide and write answers to questions received from health authorities.
- 5+years' experience in a pharmaceutical/biotech environment including not less than 4 years of experience with CMC regulatory related activities.
- BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
- Experienced with change control systems, and authoring and reviewing FDA pre and post-approval CMC changes requiring eCTD format for submissions.
- Worked with multi-disciplined teams in the bio-pharmaceutical industry and with internal and external partners.
- Excellent technical writing and communication skills, attention to detail and formatting.
- Inform management in advance of barriers to meeting deadlines.
- In-depth knowledge of USP/Eu. Ph. and Code of Federal Regulations (CFR).
- Working knowledge of cGMP's and has worked with writing template tools.
If you are aligned as for career background and you are ready to make a move to an incredibly innovative company with multiple products that are cutting edge, please send your CV immediately to Katie at email@example.com!