Senior RA/Technical Writer
2 weeks ago
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Days Left: 28 days, 3 hours left Apply Position Details: Industry: Pharmaceutical Job Title: Senior RA/Technical Writer (CMC) - Remote Duration: 12+ Months (+Potential for extension) Pay Range: $60-$85/hr (Based on experience level) Description:
- We are seeking a highly motivated individual with late-phase CMC technical experience , including technical and regulatory submission experience.
- This position is part of the Process Development organization and in this role, this individual will be supporting the internal Process Development teams. In the near-term, this role will support time critical CMC Regulatory submissions.
- Longer-term, this individual will be embedded in technical teams within the Process Development department supporting CMC aspects of our growing pipeline projects.
- Author and Finalize appropriate Module 3 documents and Response to Agency Questions in collaboration with Regulatory CMC and Technical Subject Matter Experts
Experience in analytical method development of vector and T cell, extended characterization of vector and T cell products, awareness of ICHs and global compendial requirements governing analytical development and characterization/comparability of Advanced Therapy Medicinal Products and vector intermediates.
- 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant experience
- Experience CMC/Module 3 regulatory submissions
- Experience in technical writing and proficient in high quality writing
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing and analytical and process development
- Thorough knowledge of biologics analytical and process development is essential. Cell therapy process development experience is highly desired
- Knowledge of product lifecycle - Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
- Working knowledge of regulatory requirements for biologics, pharmaceuticals and medical devices
- Must be able to function and contribute as part of a team, have excellent communication skills and contribute to team based decisions
- Ability to think critically, and demonstrated troubleshooting and problem solving skills
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- Well-developed computer skills and fluent with MS office applications
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
- Technical Witing
- Technical Writer
- CMC
- Chemistry Manufacturing and Control
- Module 3
- Stability
- method eevelopment
- biologics
- biologicals
- biotechnology
- cell therapy
- gene therapy
- CAR-T
- aseptic techniques
- Recruiter
- Phone
- Niharika Shrivastava
- niharika.shrivastava@collabera.com
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