Technical Writer - Pharma Industry - Intellectt INC

Job Title: Technical Writer
Location: Concord, NC
Duration: 6+Months on W2Contract

Job Description:

We are looking for an experienced Technical Writer with a strong background in the pharmaceutical industry to join our team. The successful candidate will be responsible for developing, reviewing, and managing a high volume of Standard Operating Procedures (SOPs), training manuals, and other essential documentation for a new pharmaceutical site. This role requires meticulous attention to detail, strong technical writing skills, and the ability to handle and organize 50-60 documents at a time in a highly regulated environment.

Key Responsibilities:

• Develop and Write SOPs: Create clear and detailed Standard Operating Procedures (SOPs) that comply with Good Manufacturing Practices (GMP) and other industry regulations.
• Training Manuals: Author comprehensive training materials for various departments, ensuring they are well-structured and easy to follow for end-users.
• Document Control and Management: Manage and organize a large volume of documents (50-60 at a time), ensuring all materials are accurate, up-to-date, and compliant with regulatory standards.
• Collaboration: Work closely with cross-functional teams, including Quality, Manufacturing, R&D, and Regulatory Affairs, to gather information, validate content, and ensure consistency in documentation.
• Compliance and Review: Ensure that all documents adhere to internal standards and regulatory requirements, including FDA, GMP, and ICH guidelines.
• Document Revisions: Update and revise existing SOPs and training materials as needed, ensuring continuous improvement and accuracy in all documentation.
• Onboarding and Training: Assist with the development of onboarding materials and training programs for employees, focusing on new site-specific procedures and compliance requirements.
• Regulatory Audits Support: Provide documentation and support during regulatory inspections and internal audits, ensuring compliance with local and international regulations.
• Content Formatting and Consistency: Ensure that all documentation follows company formatting and style guidelines for consistency and clarity.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, English, Communications, or a related field.
• 5+ years of experience as a Technical Writer in the pharmaceutical or biotech industry.
• Proven experience in writing SOPs, training manuals, and other technical documents in compliance with GMP, FDA, or other regulatory standards.
• Experience managing and controlling large volumes of documents, with the ability to handle 50-60 documents simultaneously.
• Strong knowledge of pharmaceutical processes and regulatory documentation requirements.
• Excellent written and verbal communication skills with a keen eye for detail.
• Ability to work independently and manage multiple projects with tight deadlines.
• Familiarity with electronic document management systems (EDMS) such as Veeva, Master Control, or others.

Preferred Qualifications:

• Experience working on projects for new site development or product launch.
• Strong understanding of pharmaceutical validation processes, including IQ, OQ, PQ documentation.
• Project management skills to manage multiple documentation tasks simultaneously.
• Experience with training program development for new site implementations.

Personal Attributes:

• Ability to collaborate across teams and departments.
• Strong organizational and multitasking skills.
• High attention to detail and quality.
• Comfortable working in a fast-paced, deadline-driven environment.