Technical Scientific Writer- II

Job Description

Job Summary:

• We are seeking a technical writer who will author and review Analytical Test Methods to commercialize procedures for the QC testing area by working closely with method experts.
• The candidate may also author and review documents supporting regulatory submissions working closely with regulatory groups.
• The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Duties and Responsibilities:

• Authoring and critically reviewing technical documents including Regulatory Filing sections and Analytical Test Methods.
• Authoring and reviewing documentation compliant with current Good Manufacturing Practices (cGMP), including Second Person Review or Second Scientist Review.
• Participate in group initiatives related to document standards, template development, internal processes, and other aspects of document management.
• Collaborate closely with key stakeholders.

Education:

• Minimum qualification- BS/BA in life sciences/engineering is required.
• Master’s degree/PhD preferred.

Required Experience and Skills:

• At least 2 years working experience in a cGMP laboratory environment.
• Experience in the biopharmaceutical manufacturing industry, such as in biologics or vaccines commercialization, technical operations, or quality control.
• Strong oral and written communication skills.
• Work independently and within cross-functional teams.
• Maintain a proactive and service-oriented mindset.
• Experience with MS Office and document repository systems.

Preferred Experience and Skills:

• Experience with analytical method validation and transfer according to ICH and USP guidelines.
• Experience with laboratory data management systems.

Software Skills:

• MS Office Suite.

Personality:

• Detail oriented.
• Excellent writing skills.
• Collaborative.
• Good communication and interpersonal skills.