Technical Writer
A Mid-Size Pharmaceutical Manufacturing company is seeking a skilled and detail-oriented Technical Writer to join their team. The ideal candidate will have a strong background in scientific writing and a thorough understanding of pharmaceutical regulations and documentation requirements. As a Pharmaceutical Technical Writer, you will collaborate closely with cross-functional teams to create, revise, and maintain a wide range of technical documents critical to the development, production, and regulatory compliance of pharmaceutical products.
The Technical Writer will have the following responsibilities...
- Documentation Creation: Develop and maintain comprehensive technical documents including, but not limited to, standard operating procedures (SOPs), batch records, validation protocols and reports, regulatory submissions, and quality assurance documents.
- Regulatory Compliance: Ensure all documentation complies with relevant regulatory requirements such as FDA guidelines, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and International Council for Harmonisation (ICH) guidelines.
- Collaboration: Work closely with subject matter experts, scientists, engineers, regulatory affairs professionals, and other stakeholders to gather information and ensure accuracy and completeness of technical documentation.
- Review and Revision: Review existing documents for accuracy, clarity, and compliance with internal standards and regulatory requirements. Update and revise documents as necessary to reflect changes in processes, procedures, or regulations.
- Process Improvement: Identify opportunities for process improvements in documentation creation, management, and distribution. Implement best practices to enhance efficiency and effectiveness in documentation processes.
- Training Support: Provide support for training programs by developing training materials, presentations, and manuals to ensure understanding and compliance with documented procedures and protocols.
The Technical Writer should have the following qualifications...
- Bachelor's degree in pharmacy, pharmaceutical sciences, life sciences, chemistry, or a related field.
- Proven experience (3 years) in technical writing within the pharmaceutical industry, preferably in a regulated environment.
- Strong knowledge of pharmaceutical regulations and guidelines, including FDA regulations, GMP, GCP, and ICH guidelines.
- Excellent writing, editing, and proofreading skills with a keen attention to detail.
- Proficiency in Microsoft Office Suite and document management systems.
- Ability to work independently and collaboratively in a fast-paced environment with changing priorities.
- Excellent communication and interpersonal skills, with the ability to effectively interact with cross-functional teams and stakeholders.
Benefits:
- Competitive Salary
- Health, dental and vision insurance
- 401k match
If you are interested in the position of Technical Writer, please don't hesitate to apply!
