Key Skills

Job Description

We are Akkodis. We put the talents, skills and ambitions of our Consultants first. Because we continuously offer you challenging projects, you continue to develop and you can realize your ambitions. This is our view on good employment practices. We, Akkodis Life Sciences, offer you internal and external projects in the field of QA, QC, PV, RA, R&D, Supply Chain and related. We have +/- 70 Consultants working at the EMA, Astellas, Unilever, Corbion, MSD, Organon, Aspen and many more! We, Akkodis Life Sciences, are looking for a Scientific Officer who can strengthen the team at our customer, European Medicines Agency, in Amsterdam. Role summary As Scientific Officer – Labelling Specialist, you will contribute to ensuring the quality of Product Information (PI), including invented names and pack design, supporting the safe and effective use of medicines while taking risk minimisation measures into account. You will work closely with relevant specialists to ensure Product Information standards are effectively implemented and that the documentation for individual medicinal products is accurate, consistent and of high quality. You will also take a proactive approach to maintaining quality and standards across products, translating good practices where relevant and providing advice and guidance to multidisciplinary product teams. Your responsibilities are In this role, you will: Ensure the quality and consistency of Product Information throughout the review process; Maintain Product Information templates and standards for mock-ups and specimens; Ensure scientific claims made in Product Information are evidence-based and aligned with SmPC guideline principles; Identify and address risks of medication errors related to labelling aspects; Assess Product Information, its translations, invented names, mock-ups and specimens; Provide advice on Product Information guideline principles; Support EMA Committees and Working Parties regarding guidelines, core SmPCs (Summary of Product Characteristics) and templates impacting labelling; Work within a multidisciplinary team including EMA Product Leads, Risk Management Specialists and Quality Specialists to support the development of complete and accurate Product Information; Support the operational activities of the Quality Review of Documents (QRD) Working Party and Name Review Group (NRG), including agendas, Tables of Decisions and coordination with relevant committees; Provide scientific, regulatory and procedural support relating to the development, evaluation, authorisation and surveillance of medicinal products; Apply relevant EU pharmaceutical legislation to EMA activities; Contribute to regulatory and/or procedural guidance documents and provide training where required; Respond to internal and external queries related to labelling activities; Liaise with internal and external stakeholders and subject-matter experts; Contribute to Scientific Committee meetings, Working Parties, Working Groups and Advisory/Expert Groups; Prepare and contribute to communication and regulatory documentation for allocated procedures. Role specific duties & responsibilities You have: A completed university degree of at least three years in a relevant Life Science field, such as Biology, Chemistry, Biochemistry or Pharmacy; Up to 3 years of relevant full-time professional experience; Experience within a competent authority in medicines regulation, the pharmaceutical industry, healthcare or an academic environment; Experience with the scientific, regulatory or procedural aspects of the research, development, authorisation, production or supervision of human or veterinary medicinal products; Experience working with medicinal products containing medical devices and the associated regulatory framework; Strong knowledge of SmPC guideline principles and their application in ensuring scientifically robust Product Information; Strong knowledge of QRD, NRG and mock-ups/specimens guidance and review tools; Sound knowledge of regulatory procedures and the regulatory and legal framework relevant to pharmaceutical labelling; Experience with Product Information and/or pharmaceutical labelling activities; Proven document management skills and excellent attention to detail; Strong organisational skills and the ability to work to demanding deadlines; Excellent communication and stakeholder-management skills; Scientific writing skills; Professional proficiency in English; Proficiency in MS Office. Communication and professional contacts In this position, you will work with colleagues and stakeholders across EMA and the wider European regulatory network. In particular, a Scientific Officer will: Liaise with internal and external stakeholders, interested parties and subject-matter experts; Coordinate, support and contribute to effective communication and stakeholder relationships; Communicate daily with colleagues across EMA and extended product teams regarding the management of regulatory procedures; Prepare and contribute to communication documents for allocated procedures; Contribute to the preparation of Scientific Committee meetings, Working Parties, Working Groups and Advisory/Expert Groups, including providing scientific support where applicable; Explain and interpret policies, systems and processes and contribute to responses to complex scientific or regulatory enquiries. Experience & Background A completed university degree of at least three years in a relevant Life Science field, such as Biology, Chemistry, Biochemistry or Pharmacy; Up to 3 years of full-time relevant professional experience; Experience within a competent authority in medicines regulation, the pharmaceutical industry, healthcare or an academic environment; Experience with the scientific, regulatory and/or procedural aspects of the research, development, authorisation, production or supervision of human or veterinary medicinal products; Experience working with medicinal products containing medical devices and the associated regulatory framework; Experience with the centralised procedure; Experience liaising with regulatory authorities and/or public health authorities. Skills & Knowledge You are proactive and able to identify and resolve issues arising during labelling reviews. You combine strong analytical and problem-solving capabilities with excellent attention to detail. You are comfortable working within multidisciplinary and international teams and can communicate effectively with internal and external stakeholders. You are customer-oriented, adaptable and able to prioritise multiple activities while working to demanding deadlines. Knowledge of pharmaceutical quality, scientific evidence management, regulatory frameworks and the medicinal product lifecycle is important for succeeding in this position. What do we offer? Employment for 40 hours per week and the opportunity to work at innovative and progressing companies. You will be part of a fast growing Life Sciences team that is represented in different industries (biotech, pharma, food) and present in Life Sciences clusters in The Netherlands. Temporary contract, depending on the budget the possibility to extend; Attractive salary; The opportunity to work at the European Medicines Agency; Work-life balance with 24 to 36 holidays; Company fitness, health insurance and good pension scheme; Annual team events; Options to attend training, coaching and a personal development scheme; Career opportunities matching your aspirations and development. Are you interested in this challenge, or do you want to come in touch? Please contact your Talent Acquisition Specialist of Akkodis Life Science by sending your CV* and motivation letter to [email protected]

Core Responsibilities

Review and maintain the quality, consistency, and scientific accuracy of medicinal product information, including translations, invented names, mock-ups, and specimens, while identifying labelling-related risks. Provide scientific, regulatory, and procedural support to EMA committees and multidisciplinary teams, coordinate relevant working-party activities, and contribute to guidance, stakeholder communications, and regulatory documentation.

Requirements

Requires a university degree of at least three years in a relevant life science field and up to three years of relevant professional experience in medicines regulation, industry, healthcare, or academia. Candidates should have knowledge of pharmaceutical labelling, SmPC and QRD guidance, regulatory procedures and legislation, and experience with medicinal products, including those containing medical devices; strong communication, writing, organisational, and document-management skills are also required.

Benefits

• Fitness Membership
• Health Insurance
• Pension Scheme
• Paid Holidays
• Training
• Coaching
• Personal Development Opportunities
• Career Development Opportunities
• Work-Life Balance