Technical Writer with strong project management skills
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Ballerup
If you excel within GxP document management and technical writing, and you want to utilise all of your ideas and knowledge, this job could be your perfect match. You will be driving the development of a new overall structure for management of all GxP procedures – that is intuitive, easy to use and with relevant and high quality procedures only. Your personal efforts will make a positive and significant difference for hundreds of colleagues across all LEO Pharma’s sites.
Develop the system and set new standards for SOPs and Work Instructions
Our QualityDocs solution is called MyDoc, and it is the repository of approx. 17.000 strategic and operational procedures. Now we need to take the management system to the next level, and you are the one to make this operation a success. As such, you will develop a new document structure model/hierarchy and a clear set of additional principles to be implemented across all LEO sites.
Additionally, you are expected to be LEO Pharma’s number one expert in writing Standard Operating Procedures (SOPs) and Work Instructions (WIs). Related to this role, you will educate SOP experts in the organisation to ensure a high level of quality procedures in MyDoc that people actually want to read and which are easy to understand. You will also be role modelling for the organisation by ensuring Document Management and Training procedures are up to date and within the quality standard that you define for LEO Pharma. Your primary tasks will be to:
Detail and specify the document structure and purpose – and the scope of documents in MyDoc Define and describe principles for the new document structure in SOPs and WIs Adjust document templates, workflows, periodic review etc. Build awareness, train users and anchor the new ways of working in the lines of business Create a transformation plan and facilitate the implementation in the lines of business Facilitate a clean-up process to ensure documents out of scope for MyDoc are removed Design training material to cover initial and ongoing training of Authors and SOP Experts Develop a mandatory training programme for Authors and SOP Experts
To succeed, you must be able to connect with multiple people in various departments in order to understand needs and get input and support for your design of the new structure – naturally in compliance with rules and legislation.
Good organiser and communicator with experience from GMP environment
We are looking for a profile that knows how to organise and communicate complex information independently (we trust you to find the right way forward). You have experience as Technical Writer and motivation for taking on a more leading and coordinating role. You will need all of your coordination and stakeholder management skills including your ability to make colleagues understand the needs for change and the benefits gained. As part of this you must be able to transform multiple technical input into easy understandable and user friendly standards. Additionally your CV comprises:
Experience as Technical Writer or related – with high level English competencies 3+ years of experience from a GxP regulated industry and GMP environment Profound knowledge of cGMP and FDA requirements Good understanding of process principles Experience as facilitator and teacher/trainer Coordination/project management experience
Document Management & Training – your new team
You will join 11 colleagues focusing on enabling LEO Pharma to comply with all relevant standards, requirements and the Quality Management System. We want to drive performance based on a deeply rooted GxP learning culture founded on the right systems, processes and tools.
We are busy but never to busy to help and support each other or to have a good time together. If you like to have a good time while unfolding your skills to make a difference, you have it just like the rest of us. LEO Pharma is simply a good company to work for.
Develop the system and set new standards for SOPs and Work Instructions
Our QualityDocs solution is called MyDoc, and it is the repository of approx. 17.000 strategic and operational procedures. Now we need to take the management system to the next level, and you are the one to make this operation a success. As such, you will develop a new document structure model/hierarchy and a clear set of additional principles to be implemented across all LEO sites.
Additionally, you are expected to be LEO Pharma’s number one expert in writing Standard Operating Procedures (SOPs) and Work Instructions (WIs). Related to this role, you will educate SOP experts in the organisation to ensure a high level of quality procedures in MyDoc that people actually want to read and which are easy to understand. You will also be role modelling for the organisation by ensuring Document Management and Training procedures are up to date and within the quality standard that you define for LEO Pharma. Your primary tasks will be to:
To succeed, you must be able to connect with multiple people in various departments in order to understand needs and get input and support for your design of the new structure – naturally in compliance with rules and legislation.
Good organiser and communicator with experience from GMP environment
We are looking for a profile that knows how to organise and communicate complex information independently (we trust you to find the right way forward). You have experience as Technical Writer and motivation for taking on a more leading and coordinating role. You will need all of your coordination and stakeholder management skills including your ability to make colleagues understand the needs for change and the benefits gained. As part of this you must be able to transform multiple technical input into easy understandable and user friendly standards. Additionally your CV comprises:
Document Management & Training – your new team
You will join 11 colleagues focusing on enabling LEO Pharma to comply with all relevant standards, requirements and the Quality Management System. We want to drive performance based on a deeply rooted GxP learning culture founded on the right systems, processes and tools.
We are busy but never to busy to help and support each other or to have a good time together. If you like to have a good time while unfolding your skills to make a difference, you have it just like the rest of us. LEO Pharma is simply a good company to work for.
Information og data
Denne ledige stilling har jobtypen "Kommunikationsmedarbejder", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 12.3.2020, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Kommunikationsmedarbejder
- Ballerup
- Onsdag den 25. marts 2020
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