Current Openings

Clinical Data Manager


The primary objective of the Clinical Data Manager is to coordinate and complete in-house data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting.


  • A scientific background (BS degree or higher) with 3-5 years of clinical data management experience in the pharmaceutical/biotechnology industry.
  • Be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. MedDRA and WHO Drug coding proficiency is preferred.
  • Previous experience with reviewing data and database validation for EDC (DSG’s eCaselink is preferred) is required.
  • Knowledge of CDISC/SDTM standards is also highly desired.

Sr. Regulatory Specialist


The primary duties of this position are to compile, publish and submit eCTD compliant regulatory dossiers to the FDA and other health authorities in a timely manner, and provide Regulatory support to project teams.


The candidate should have a BS degree preferably in a scientific discipline (or equivalent knowledge and experience) and a minimum of 3 years’ experience in Regulatory Operations/electronic submissions. Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable. Good understanding of the FDA’s submission requirements and drug/biologic/device development processes is required. Good oral and written communication skills, detail-oriented, self-directing, and ability to handle multiple projects across all functional areas independently are essential.


  • Plan, compile, publish and submit Regulatory documents for IND, NDA, BLA, IDE, and PMA applications, including Amendments, Supplements, and Meeting materials to the FDA.
  • Review submission components for quality and completeness.
  • Assure all electronic submissions are in compliance with regulatory requirements and ICH eCTD specifications.
  • Maintain Regulatory submission and correspondence archives/records.
  • Provide publishing support to the Medical Writing group, as requested.
  • Provide regulatory support to other departments, as requested.
  • Assist Regulatory Director in providing regulatory strategy, intelligence, and other regulatory support to product development teams.
  • Serve as point of contact for the FDA.

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