- Actively participate in CST and other strategic meetings (when relevant), as Medical Writing representative, and closely interact with Medical, Regulatory, Biostatistics, Clinical Operations, and other functional representatives.
- Organize kick-off and review meetings for the clinical documents and ensure meeting minutes are documented. Write Clinical Study Reports, Clinical Study Protocols and amendments, Pediatric Investigational Plan, Clinical Overviews, and Clinical Summaries with the CST and present these documents to the Governance Reviewers, when applicable.
- Provide scientific and writing expertise during the development of clinical documents and ensure that these documents meet all Galapagos standards and regulatory requirements.
- Supervise timelines, meetings, and overall quality of the clinical document.
- Write the Investigator's Brochures, in close collaboration with the section owners and the nonclinical writer(s).
- Support the writing of study outlines and study concepts.
- Write Scientific Advice, Briefing Books, and responses to questions from Authorities, in close collaboration with Regulatory.
- Act as first point of contact for the external medical writer, in case of outsourcing. Provide sufficient background information and instructions to the external medical writer.
- Actively participate in Medical Writing and Biometrics team meetings.
- Adhere to existing Policies and Procedures and ensure timely completion of relevant training.
- Interact with Quality & Compliance department to follow up on audit and inspection reports and assigned Corrective Action/Preventive Action plans in timely manner; participate in audits and inspections where needed.
- Lead or contribute to Process Improvement initiatives as required.
- Adhere to existing Policies and Procedures and ensure timely completion of relevant training.
- Train and supervise Associate Medical Writers and/or Medical Writers, when applicable.
- Support the writing and/or coordination of procedural documents.
-
Technical Analyst
1 dag geleden
Ordina Mechelen, België**Your Impact**: · As a technical analyst at Ordina, your responsibility goes beyond just identifying customer needs and expectations. You also support the product owner and scrum masters in writing out user stories, and help the software engineers draw up technical specification ...
-
Bid Officer
6 dagen geleden
Planon Mechelen, België**Bid Officer**: · **Bid Officer · - Mechelen** · Are you interested in a sales career in IT? We offer you a job where you can take a relevant part in the process of selling our market leading enterprise software to international organizations. Are you an excellent commercial tec ...
-
Delphi Developer
1 dag geleden
Cochlear Ltd Mechelen, BelgiëDelphi Developer · **Job no**: 615895 · **Work type**: Permanent · **Location**: Mechelen · **Categories**: IT · - **Cochlear is a company that have transformed lives around the world**: · - **Work with a Global team**: · - **Be part of a world leading development team in implant ...
-
Product Officer English + Other Language
2 dagen geleden
Adecco Mechelen, BelgiëFor Keyence, a Japanese company specialized in high technology products such as sensors, microscopes, laser markers and vision measurement systems. The company is a global leader in automation industry responsible for delivering high-precision and innovative products to companies ...
-
Practice Manager Functional Analysis
1 week geleden
Ordina Mechelen, België**Your Impact**: · As a practice manager, you are the leader within the field of functional analysis. You are active as an expert consultant and can offer added value to our customers like no other. You are responsible for knowledge sharing and knowledge development within Ordina ...
-
Functional Analyst
1 week geleden
DXC Technology Mechelen, BelgiëAt DXC Technology, we act as an independent, trusted advisor in digitizing the client's business in Belgium. Our employees are responsible for optimizing their industry processes in the domains of HR, accounting, logistics and IT as well as developing, implementing and managing t ...
-
Process Excellence Lead
1 week geleden
Labcorp Mechelen, BelgiëAs a certified Black Belt (or equivalent), you will act as the Process Excellence local point of contact to support local Continuous Improvement initiatives, partnering with local teams and liaise with the global Process Excellence team to guarantee methods consistency, prioritiz ...
-
PMO Expert
1 dag geleden
Ordina Mechelen, België**Your Impact**: · Do you (and your grateful colleagues) rely every day on your amazing project management skills and expertise? Are you perfectly caught up with each project's status at all times? Can you spot challenges before they even surface? Then you might be our next PMO E ...
-
Agile Product Owner
4 dagen geleden
Unit-T Mechelen, BelgiëBij Unit-T zijn we op zoek naar Agile Product Owner. ben jij de geschikte kandidaat? dan meteen. · Office · Mechelen · 40 uur per week · **Wat houdt de functie in?**: · How does your day looks like? · - Take the lead in your agile team to ensure that requests are delivered on-tim ...
-
Operational Assistant Cochlear Academy
1 week geleden
COCHLEAR BENELUX Mechelen, België**About Us** · Imagine using your experience to help people around the world to hear again. We can offer a unique opportunity to join Cochlear, an iconic Australian company, leading the world in implantable hearing solutions. Our mission is to help more people to hear. · **The Op ...
-
Data Strategist
2 dagen geleden
Telenet Mechelen, België VoltijdWe are moving towards an increasingly data-driven world, with boundless possibilities. At Telenet, Data & analytics are recognized as the fuel & engine under the hood that can improve everything in our business. Within the Data Acceleration Tribe - the centralized data & analytic ...
-
Associate Analyst Finance
1 week geleden
Stanley Black & Decker Mechelen, BelgiëSTANLEY BLACK AND DECKER · **Position**:Stanley Black and Decker Leadership Development Program - Finance SLP · **Division**:Corporate · **Location**:Mechelen, Antwerp, Belgium 2 days a week in office and 3 days hybrid · Since 1843, Stanley Black & Decker has set the standard for ...
-
Junior Boekhouder
4 dagen geleden
HR-Specialist Bonheiden, België**Company** · Our client is **a world's leader** in **innovator and manufacturer of advanced control and automation systems **for the office, campus, hospitals, home,reinventing the way people live and work. · They create for example solutions to monitor your home, to manage remo ...
-
Safety Machinery Expert
1 week geleden
Etex Group Kapelle-op-den-Bos, België**About the role** · - Etex Engineering is an Etex Company oriented to manage big capex projects and also provide technical support & expertise to our internal customers, the factories. · - This position is specifically for the technical support to be provided to the Project Mana ...
-
Product Manager
1 week geleden
Knowliah Boortmeerbeek, BelgiëAbout Knowliah · At Knowliah, we empower others to be at their best. As a business, that means the Knowliah Enterprise Legal Management platform allows Corporate Legal Departments to mitigate risk, increase efficiency and demonstrate compliance, through industry-leading legal inf ...
-
Marketing Specialist Products
1 week geleden
Toyota Material Handling Europe Willebroek, BelgiëThe marketing specialist for products is primarily responsible for supporting TMHE's product management & MSCO marketing departments. · You will be responsible for supporting and driving the product offer: · - Transform ideas and concepts into strategic and effective marketing pl ...
-
Laboratory Technician Food Industry
14 uur geleden
Oxford Global Resources Vilvoorde, België**Laboratory Technician Food Industry**: · - Location: · Vilvoorde · - Contact: · Thomas De Naegel · - Job type: · Contract · - Contact phone: · - Industry: · Food and Beverages · Play a vital role in R&D ensuring food safety, quality, and regulatory compliance through hands-on l ...
-
Boiler Engineering Professionals
1 week geleden
CREANERGY Melsbroek, BelgiëThis position requires proficiency in English in speaking and writing. French is a strong asset. · **Your role**: · - You will engineer, design or verify water-tube boilers, economizers, thermal oil heat exchangers and custom-built heat exchangers for waste-to-energy plants, wast ...
-
Marketing Innovation
1 week geleden
Lantmännen Unibake Londerzeel, België**Have an appetite for more?** · Join a leading global bakery group powered by ambitious people that are truly passionate about delivering the best in everything they do. · With business in mind and people at heart we always work together to influence our road ahead. We want you ...
-
Quality Specialist Operations
2 dagen geleden
Pfizer Puurs, BelgiëAfdeling · De functie van Quality Specialist Operations situeert zich binnen de QA afdeling die verantwoordelijk is voor de uitvoering van de operationele QA-taken gerelateerd aan een bepaalde productie-, verpakkings · - of QC afdeling in de Pfizer productiesite te Puurs. · Bedri ...
Medical Writing Leader - Mechelen, België - Galapagos
Beschrijving
Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.
We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The 'make-it-happener'.
For our Galapagos organisation we are looking for a Medical Writing Leader - any location (remote job - contractor 6 month)
Scope of the job
The Medical Writing Leader (MWL) is anexpert in the writing of clinical documents (e.g. Clinical Study Protocol,Clinical Study Report, Briefing Book, Investigator's Brochure, responses toquestions from Authorities) and support the Clinical Study Team (CST) and the Project Team (PT) in the development of these documents.
Your role
Accountabilities related to compounds/studies: support the Clinical Study Team (CST) and the Project Team (PT) in the development of clinical documents.
Accountabilities not related to compounds/studies
