- Legend Biotech USA, Inc. (Raritan, NJ)
- …manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to manufacturing of cell based products as well ... as knowledge of Good Tissue Practices.Strong interpersonal and written/oral communication skills.Proven people management and leadership experience is required.Experience working with quality systems is required.Extensive knowledge of chemical, biochemical and… more
- Merck & Co. (CT)
- …results Knowledge of national and society treatment guidelines, clinical research processes, FDA regulations, and OIG, HIPAA and other ethical guidelines, laws, and ... regulations relevant to the pharmaceutical industry and its external stakeholder environment Organize, prioritize, and work effectively in a constantly changing environment Travel Up to 50% travel, including overnight #EligibleforERP Required Skills:… more
- Lundbeck (Atlanta, GA)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... REQUIRED EDUCATION, EXPERIENCE and SKILLS: Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. Must… more
- Merck & Co. (Rahway, NJ)
- …Data Quality Assessments, Documentation Review, Employee Training Programs, FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, ... Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+ 1 more}Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is… more
- Merck & Co. (Durham, NC)
- …with responding to regulatory questions with multiple agencies (eg FDA , EMA)Experience with face-to-face presentation of technically complex subjects to ... regulatory inspectors-Required Skills: Adaptability, Adaptability, Biodesign, Change Control Management, Chemical Engineering, Collaborative Communications, Continuous Process Improvement, Data Analysis, Equipment Troubleshooting, Good Manufacturing Practices… more
- Eisai, Inc (Dallas, TX)
- …strongly preferred Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliant practices, and OIG guidelines are ... required. Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: Interested and skilled in communicating complex data sets and the ability to be seen as a… more
- Cipla (Hauppauge, NY)
- …Packaging Area Standard Operating Procedures and Food and Drug Administration ( FDA ) regulations Ability to communicate effectively and clearly, both written and ... verbally in English. Comply with safety and quality regulatory standards when packaging products.Ensure products are packaged in accordance with packaging time standards. Flexible and Adaptable: Copes with ambiguity, change and uncertainty effectively. Not… more
- Cipla (Hauppauge, NY)
- …and other business applications. Strong knowledge of GMP, regulatory requirements ( FDA ), and pharmaceutical manufacturing processes. Prior experience in RX and ... generic pharmaceutical manufacturing/packaging is a plus. Effective interpersonal relationship skills and the ability to work in a team environment. Proficiency in the English language to include usage, spelling, grammar, and punctuation. Must have current… more
- Aequor (Aliquippa, PA)
- …(SOPs) and related controlled documents. Interact as needed with the FDA and other governmental inspection agencies, ensuring accurate, professional representation ... of operations and compliance status.Basic Qualifications Master's Degree OR Bachelor's Degree and 2 years of Life Science or Business experience (preferably in the biotechnology or pharmaceutical industry) OR Associate's Degree and 6 years of Life Science or… more
- Merck & Co. (St. Louis, MO)
- …results -Knowledge of national and society treatment guidelines, clinical research processes, FDA regulations, and OIG, HIPAA and other ethical guidelines, laws, and ... regulations relevant to the pharmaceutical industry and its external stakeholder environmentMust be able to organize, prioritize, and work effectively in a constantly changing environment--Preferred capabilities:Recognition for scientific excellence in… more
