Technical Writer, Analytical

In this role, you will be instrumental in producing clear and concise documentation for a range of pharmaceutical projects. The ideal candidate will possess a robust background in technical writing, exceptional attention to detail, and a profound understanding of pharmaceutical terminology and processes.

Specific Duties:

· Collaborate closely with cross-functional teams to collect information and gain a comprehensive understanding of project requirements.

· Develop and uphold technical documentation, encompassing a range of materials such as standard operating procedures (SOPs), Design of Experiments (DoEs), experimental plans, protocols, batch records, validation reports, specifications, change control documentation, CAPAs, investigations, deviations, CMC modules, and support regulatory submissions.

· Translate intricate scientific and technical data into clear, concise, and easily understandable documentation tailored for both internal and external stakeholders.

· Ensure strict adherence to regulatory standards and guidelines, including but not limited to FDA regulations, ICH guidelines, and GMP requirements.

· Review and meticulously edit documentation to guarantee accuracy, consistency, and alignment with company standards.

· Collaborate effectively with subject matter experts to validate technical content and ensure alignment with project objectives.

· Oversee the entire documentation lifecycle, including version control, updates, and appropriate archival procedures as deemed necessary.

· Remain abreast of evolving industry trends, regulations, and best practices pertinent to technical writing within the pharmaceutical sector.

· Provide robust support during audits, inspections, reviews, and other quality control activities as required.

· Actively contribute to initiatives aimed at refining documentation practices and improving efficiency within the organization's processes.

Education and Experience:

· Bachelor's or master’s degree in Biological or Biochemical sciences.

· Minimum of 3 years of relevant experience as a Technical Writer in the pharmaceutical industry or a related field.

· Proficient writing and editing skills, demonstrating the ability to communicate complex concepts clearly and effectively.

· Expertise with pharmaceutical terminology, processes, and regulatory requirements.