PDP | Talent Acquisition Specialist | Life Science Engineering | CQV & Project Controls
JOB SUMMARY
The Technical Writer is responsible for creating, editing, and maintaining clear, accurate, and compliant documentation to support all aspects of pharmaceutical operations, research, and manufacturing. The position ensures documentation meets regulatory standards, aligns with company policies, and enables effective communication and knowledge transfer among internal and external stakeholders.
MAIN RESPONSIBILITIES
Prepare, review, and revise technical documents including Standard Operating Procedures (SOPs), protocols, validation documents, batch records, investigation reports, manuals, and regulatory submissions.
Ensure all documentation is accurate, clear, concise, and compliant with regulatory requirements such as FDA, EMA, and ICH guidelines.
Work closely with subject matter experts (SMEs), scientists, engineers, quality assurance, and regulatory teams to collect and verify technical information.
Edit and proofread technical documents for grammar, consistency, terminology, formatting, and content accuracy.
Maintain document templates according to company and industry standards; support continuous improvement of documentation practices.
Manage documentation lifecycle using document management systems (DMS) to ensure proper version control, review, approval, and archiving.
Interpret and translate complex technical concepts, data, and requirements into user-friendly documents for various audiences.
Contribute to training material development, work instructions, and internal communications as necessary.
Assist in regulatory inspections and audits by compiling and presenting required documentation.
Stay up to date with changes in industry regulations, standards, and best practices related to pharmaceutical documentation.
EDUCATION/QUALIFICATIONS
Bachelor’s degree in a scientific, technical, or communications field (Life Sciences, Chemistry, Pharmacy, Engineering, English, or equivalent).
2+ years of experience in technical writing within the pharmaceutical or life sciences industry (including GMP, GLP, or regulatory environments).
Strong understanding of documentation requirements in a regulated pharmaceutical environment.
Excellent written and verbal communication skills, with the ability to tailor content to diverse audiences.
Proficiency in Microsoft Office suite and familiarity with electronic document management systems (e.g., Veeva, MasterControl, Qumas, or similar).
Strong organizational skills and attention to detail, with the ability to manage multiple projects and deadlines.
Ability to quickly learn and translate complex technical concepts.
Collaborative mindset and capability to work effectively with cross-functional teams.
Knowledge of cGMP, FDA/EMA regulatory requirements, and industry documentation standards is highly desirable.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering Services, Pharmaceutical Manufacturing, and Biotechnology Research
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