What are the responsibilities and job description for the Global Clinical Labeling position at Freyr?
Qualifications:
Proficient with Microsoft Office applications. Demonstrate excellent attention to detail Demonstrate strong communication and interpersonal skills to work in team environment Demonstrate excellent oral and written communication skills Provide detailed analysis of issues and collaborate for creative problem solving Prefer at least 3 years of pharmaceutical industry experience Education: College degree (BA/BS), preferably in Sciences. This is a remote role but may require onsite availability to West Point, PA. if needed.
Responsibilities:
Global Clinical Supply Packaging Operations is seeking a highly motivated individual to support clinical supply label production. The successful candidate should have working knowledge of clinical packaging operations including the understanding that all clinical supplies and associated documentation are processed according to Standard Operating Procedures, study protocols, GMP’s/GDP’s and appropriate safety requirements to meet exacting standards defined by Merck, the FDA and EU or other international regulatory agencies. Activities may include: - Coordination of Label Translation Requests - Generation of Clinical Label Proofs - Liaise with country-level Clinical Operations personnel or Regulatory Affairs to request/ revise translations, address questions, update regulatory requirements, etc. - Maintain Label Translations library - Interpret clinical study designs and Clinical Supplies Specification documentation - Understand and maintain study blinding - Coordinate booklet label manufacturing at vendors - Perform visual inspection and accountability for label proofs - Collaborate with partners and stakeholders within the Clinical Supply Chain
Job Types: Full-time, Contract
Schedule:
- 8 hour shift
Work Location: One location