Drug Master File Manager
Job Drug Master File Manager
As a Synthon drug master file (DMF) manager you are (co-)responsible for compiling and maintaining the drug master files (ASMFs/DMFs) for your projects in order to globally obtain and maintain the marketing authorizations for Synthon and its marketing partners. The DMF consists among others of a description of the production process, the specifications, chemical properties, analytical procedures, and stability data of the active pharmaceutical ingredient (API) in a medicine.
To prepare you for your responsibilities, we are offering you a training program within the department. One of your team members will be your buddy; he or she will teach you the basic principles of the regulatory environment. After training under close supervision for a period of approximately one year, you will be responsible for your own projects (around 15). You will work in a team to realize the best strategically advantageous DMF. To compile the DMF you will use the knowledge and research data as obtained by multiple internal departments as well as from external suppliers. Next to that your tasks will include all relevant negotiations and correspondence with the competent authorities.
The drug master file manager reports to the head of the DMF department.
Synthon is an international pharmaceutical company, and a leader in the field of generic human medicines. Founded in 1991, Synthon has been working in biotechnology since 2007 and is developing rapidly into a specialty pharmaceutical company. Our mission is to make healthcare more affordable and to increase access to important medicines through the provision of high quality generics and new biological and chemical entities - specifically in the therapeutic areas of oncology and autoimmune diseases. Currently our products are approved by regulatory agencies in more than 90 countries and marketed through strategic partnerships and – in dedicated areas – through direct sales.
Synthon’s head office is based in Nijmegen, the Netherlands, and the company has affiliates in eight other countries. In 2016 it recorded a turnover of EUR 258 million. The company employs around 1,900 staff of whom over 500 work in Nijmegen.
We are interested in result-oriented people with a sharp mind and entrepreneurial spirit, who can contribute to what we do best: delivering affordable and innovative medicines to those in need.
Profile Drug Master File Manager
Your qualifications are:
· Master’s degree or Ph.D. in chemistry with preferably 2 years of working experience or bachelor’s degree with a minimum of 3-5 years of professional experience
· Excellent command of the English language in speaking and writing
· Regulatory affairs experience is a plus
· Self-motivated with the ability to work in a team
· Strong organizational skills, detail-oriented but capable to simultaneously deal with various projects.
In interviews you will be able to demonstrate that:
You are a pleasant person with a flexible working attitude. You enjoy searching for innovative solutions for complex technical and regulatory challenges. You are accurate and can quickly switch between different topics and projects. You are able to communicate clearly and completely, both in writing and speaking. Key parts of your interpersonal skills are fluent interaction with and influencing others, internally as well as externally. You are capable to independently work in a multidisciplinary project team to obtain the best strategically advantageous DMF and are able to discuss all important matters in a coherent and concise manner with the project manager.
Contract hours: preferably fulltime (40 hours); 4 days a week (32 hours) is negotiable.
Salary: depending on experience.
Please send your application before 20 October 2017. The first round of interviews will take place on 30 October 2017 and the second round of interviews will take place on 6 November 2017.
For more information please contact Martijn Klop, head of the DMF department, preferably between 16:00 and 17:00 hrs at tel. +31(0)24 272 77 00. If you are interested in this challenging position, we look forward to your application. You can apply via the apply button or link, which will directly lead you to our website.