Senior Technical Specialist, Us Life-Cycle Insights

Senior Technical Specialist, US Life-Cycle Insights

Headquartered is in Aventura, FL, Telecommuting Permitted

Responsible for providing and maintaining proprietary information related to drug and biologic loss of exclusivity, life cycle forecasting, competitive landscape, patent, legal, and regulatory developments and related data and analytics projects for various drug products. Build new analyses including: Study product; Patent search; Describe patents; Draft loss of exclusivity analysis requiring: Assess infringement: whether patent covers the branded products and whether competitors may be able to avoid it; Assess validity: review patent examination history, specification Competitive landscape: researching generic/biosimilar approvals, on the market status, whether on the market products infringe branded patents. Responsible for database updating (patent and regulatory). Provide information on new drug product launches. Analyze new patents, new indications, and litigation developments updating existing analyses when new information develops. Review/edit analysis performed by other team member including builds of new analyses, updates to the previous builds – new patents/patent applications, generic/biosimilar updates. Working with the research team to monitor and track patent litigation and approval updates, perform legal, regulatory, and scientific research. Assist other members of the team with patent searching, scientific consulting, and legal/regulatory research.

REQUIREMENTS FOR THE POSITION ARE:

Applicant must have a Master’s Degree in Pharmacy, Pharmacology or Pharmaceutical Sciences and one year experience in evaluation of patents to validate potential opportunities for various drug products. Demonstrated experience and knowledge of pharmaceutical drug life cycle and FDA drug approval pathways, including loss of exclusivity, small molecule brand drugs, New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) and 505(b)(2) NDAs. Must have hands-on-experience in Intellectual Property (IP), Drug Regulatory and product development prospects in different therapeutic areas. Applicant must have experience using the following databases: SciFinder, Orbit, IMS, Newport, Thomson Integrity, STN, USPTO, EPO, WIPO, CA Register, and Indian patent site. Must have critical thinking, using logic and reasoning to identify and provide valuable insights. Strong written communication skills are required. Domestic travel is required, approx. 5%. Headquartered is in Aventura, FL, Telecommuting Permitted. 40 hrs/wk. M-F 8am-5pm. Must have proof of legal authority to work in U.S. To be considered, please send resumes to IPD Analytics LLC at [email protected]