Head of Non-Clinical Writing Leaders - Romainville, FR (other EU locations possible)
Pleased to meet you, we are Galapagos, a dynamic fast growing biotech company with offices in various locations all over Europe and in the US.
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 want to challenge the impossible. 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-happeners’.
We are looking for a Head of Non-Clinical Writing Leaders - Romainville, FR (other EU locations possible)
Scope of the job:
The Head of Non-Clinical Writing (NCW) Leaders is accountable for the elaboration, implementation and execution of the technical writing aspect of nonclinical sections of internal or regulatory documents. The Head of NCW Leaders is accountable for the data integrity of nonclinical Pharmacology and PreClinical Development data, reports and summaries.
- Set out the most efficient organizational structure in the NCW Leader team, managing roles to cover responsibilities and determining and managing the team budgetary needs
- Manage staff recruitment, team building, mentoring and coaching
- Provide the NCW expertise (training and internal expert network) during the development of non-clinical sections of regulatory documents (e.g. Briefing Book, Investigator’s Brochure, NDA, responses to questions from Authorities), and ensure that these documents meet all Galapagos standards and regulatory requirements.
- Assign NCW Leaders to projects based on needs across the portfolio in coordination with the Heads of Safety and ADME leaders
- Collaborate with multidisciplinary team members and other subject matter experts to drive the development of Pre-Clinical drug candidates
- Select and manage vendors delivering NCW services, in line with Galapagos’ operational model
- Execute the PCD elements in the Master Audit plan and CAPA plans in close collaboration with the Quality Management department
- Identify and implement the necessary PCD Information Systems
- Supervise timelines and overall quality of these documents
- Provide instructions to the toxicology CRO regarding the study report templates.
Who are you ?
- The successful candidate has at least an MSc degree in sciences, with at least 10 years of hands-on medical writing experience within the life-science / pharmaceutical industry
- You are used to write documents like protocols, non-clinical study reports, briefing books, investigator brochures, and other regulatory documents (response to questions from authorities, …).
- Furthermore you have profound understanding and working knowledge with respect to the preparation of documents for submission for marketing approval.
- You have successfully managed teams in the past
- You show proficiency with MS-Word and preferably with document management systems.
- You should be able to organize and plan multiple priorities, and have the ability to coordinate and collaborate with the CROs.
- You’re familiar with the new SEND process.
- Last but not least, having excellent interpersonal and communication skills is required, together with being fluent in English (oral and in writing).
What’s in it for you ?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!