What are the responsibilities and job description for the CMC Technical Writer - III position at Sharp Decisions?
Job Details
Technical Writer || Remote
Sharp Decisions Inc. is seeking a Technical Writer for our client based. This is a Remote position with an initial 6 -month contract, with the potential for extension and the rate for this role is $82/hr on W2.
Employment Type: W2 only.
Responsibilities (include but are not limited to):
Requirements:
Sharp Decisions Inc. is seeking a Technical Writer for our client based. This is a Remote position with an initial 6 -month contract, with the potential for extension and the rate for this role is $82/hr on W2.
Employment Type: W2 only.
Responsibilities (include but are not limited to):
- 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.
Requirements:
- Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent with 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 Microsoft 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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Salary : $82
