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.

Contract

Fixed-term for six months, with possibility to renew.

Tasks

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
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

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

Desireable 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

About TWi

TWi is an exciting high-growth company. We are a team of technical content creators and consultants supporting leading technology and life sciences companies to create the ideal end-user experience for their internal and external clients.

As knowledge transfer professionals, we are experts in technical writing, eLearning, translation and localization, content strategy, and information for emerging technologies. We are focused on making it easy for our clients to work with us. Whether we’re working on Instructions for Use for a medical device, process documentation for developing life-saving drugs, or an online help system for a software application, we guarantee high-quality results and timely delivery.

Our team members enjoy an open and communicative culture, and opportunities to contribute, learn, grow, and flourish every day in a dynamic environment. We’ve championed flexible working arrangements, including varied work-from-home options, from our beginning. TWi was founded on the principle that all communication, no matter how technical, is about people. We put that into practice by making sure that everyone on our team is valued, included, and supported.

Our Values

Our company values give us a framework for leadership and daily decision making, they are what makes TWi a great place to work. Although we hail from all walks of life and speak dozens of languages, our staff share and work towards a common goal and vision for the company. These values are the embodiment of how we as a company and individually behave and present ourselves both internally and externally to our colleagues and our customers.

Teamwork - we support and work for each other.
Integrity - we keep our promises.
Quality - we are dedicated to excellence.
Customer focused – we create value for our customers.
Making a difference – we care.
Measured risk taking – we learn from successes and failures.

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