Technical Writer: Life Sciences

at  Technically Write IT

DESCRIPTION

We are looking for someone with a background in Pharma / BioPharma or MedTech and experience in regulatory documentation, writing, and information design. The successful candidate will support a project with a leading global Biopharmaceutical company. The main activities of the role will be to format, edit, and update technical documentation such as SOPs, BMRs, protocols, and other technical reports as necessary. The successful candidate will possess a high level of initiative, energy, and motivation, as well as excellent organisational skills.

ESSENTIAL REQUIREMENTS

• Level 6/Diploma or higher qualification in engineering, science, technical writing, English, or a related discipline.
• Previous technical writing experience.
• Committed to understanding and applying quality processes.
• Proficient with MS Office suite, particularly Excel, and Word.
• Able to identify and resolve problems using own initiative.
• Excellent communication and interpersonal skills, both internally and with client contacts.
• Excellent written and spoken English.
• Strong ability to work to tight deadlines.
• Flexible working approach with a can-do attitude to adapt to the changing business needs of a growing company.
• Willing to learn new tools as required.
• Able to explain concepts clearly and concisely.
• Able to manage and report on assigned tasks in accordance with agreed priorities.
• Comfortable working independently and as part of a team.

DESIRABLE REQUIREMENTS

• cGxP experience in Pharma / BioPharma / MedTech or equivalent industry.
• Experience in statistics and statistical software such as Minitab.
• Experience in validation documentation.
• Experience with Life Sciences regulatory documentation
• Experience with technical/technology transfer documentation

• Support the formatting, updating, drafting, and authoring of BMRs, SOPs, protocols, and other technical reports in conjunction with the various departmental subject matter experts (SMEs).
• Draft regular reports to monitor process consistency using statistical analysis in conjunction with technical owners and the quality team.
• Become an SME / Super-User of the controlled document system to facilitate the authoring, review and approval documentation process.
• Support non-conformance and change control processes.
• Be proactive and collaborative in troubleshooting and resolving issues with documentation, training and systems.
• Contribute to internal and innovation related projects.