What are the responsibilities and job description for the Pharmaceutical Labeling Specialist(Associate )- PLSA25-19531 position at NavitsPartners?
Title: Pharmaceutical Labeling Specialist(Associate)
Location: Millsboro, DE 19966 (Hybrid; 3 days onsite with Tuesday and Wednesday fixed onsite)
Duration: 12 Months
Job Description
Minimum Education: Associate degree.
Preferred Education: Bachelor/Master's degree in Life Science.
Required Experience and Skills:
- With Associate, minimum 5-7 years of relevant experience within pharmaceutical labelling experience.
- With a Bachelor's, a minimum of 4-6 years of relevant experience in pharmaceutical labelling experience.
- With a Master's minimum of 2-5 years of relevant experience in pharmaceutical labelling experience.
- Require someone with a scientific background or familiarity with medical terminology.
- Require someone with excellent proofreading skills.
- Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, SharePoint, and ADOBE.
Preferred/nice to have: Industry - Pharmaceutical Industry/Vaccine manufacturing/Medical and Biotechnology.
Personality:
- Attention to detail.
- Team Player.
- Able to follow directions.
- Can work independently once the training is complete.
- Able to make sure that regulations are met.
- Excellent communication and writing skills.
- Open minded.
Must have:
- Regulatory labeling content review as per FDA guidelines.
- Quality check of labeling content errors.
- Label artwork, and label design review.
- Support the preparation of labeling documents, coordinating labeling document submissions to regulatory bodies.
- Looking for someone with labeling expertise in the pharmaceutical industry, vaccine manufacturing, or GMP.
Typical day:
- Very intensive label-oriented job
- Need someone to hit the ground running.
- Label review and submission of labeling documents and artwork
- Label artwork, and label design review.
- Quality check for label content and formatting as per FDA guidelines.
- Support the team with the review, and revising labeling.
- Attention to detail.
- Will prepare the label content following SOP’s and FDA regulations.
Responsibilities:
- The client is a Biotechnology Center of Excellence that manufactures, fills, packages and distributes vaccines for animals.
This position is responsible but is not limited to the following duties:
- Prepare new/revised label packaging for regulatory submissions to the USDA and maintain regulatory documents to ensure site compliance.
- Support regulatory filing submissions with the USDA for both domestic and international product packaging.
- Independently work with internal stakeholders, regulated packaging processes, and system workflows to revise or draft new packaging for vaccine biologicals for both US (domestic) and international markets.
- Ensure prompt availability of labels and artworks and liaise with departments such as Marketing, Pharmacovigilance, and Technical Services to ensure compliance with established regulations.
Training
- Training with the USDA regulations on packaging, ARTIS computer system, and internal processes and workflows for packaging submissions and filing maintenance.
Training Type: Corporate Development – Coaching has context menu
