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The CCDS & Labeling Artwork Contractor role is responsible for artwork development, implementation, and change control of new and revised labeling components processed for assigned Astellas products and areas within the Americas region. Ensures compliance with internally approved content and internal procedures and alignment with business needs.
• Assists in the development of labeling for Astellas managed products and ensures labeling is created in accordance with internal quality documents meets is in accordance with local regulatory specifications.
• Coordinates with Label Management and other key stakeholders to provide guidance to typesetter with regards to the preparation of artwork for new and revised labeling. Proofreads, edits, and approves all artwork in the system as required on the behalf of local Regulatory Affiliate and/or local Business Partners.
• Collaborates with CCDS and Labeling Lead and ROW Labeling Lead on submission and implementation strategy for labeling artwork.
• Maintains all manual and electronic current/historical labeling files.
• Prepares the labeling component and summary of changes for all annual reports; Drug Listings and USPC submissions (twice annually).
• Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.
• Actively manages and prioritizes workload to ensure timelines are met.
Contractbeheerder - Medewerker Contractbeheer
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group's EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group's commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
• Bachelor's degree;
• Previous artwork or graphic design experience;
• Proven ability to prioritize and multi-task with supervision based on interactions with project team members;
• Excellent written and verbal communication skills (native and non-native English speakers) with the ability to meet regulatory requirements and standards while maintaining effective relationships;
• Strong organizational skills and high level of attention to detail;
• At least 1 year previous relevant industry experience, with previous experience in RA, labeling or medical writing a plus;
• Basic understanding of relevant FDA/ICH regulations & guidelines a plus;
• Understanding of regulatory compliance concepts as they relate to performing immediate job functions.
071 566 57 24
Kort Rapenburg 6