Current Openings

Clinical Data Manager

PRIMARY OBJECTIVE OF THE POSITION:

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.

QUALIFICATIONS:

  • 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

PRIMARY OBJECTIVE OF THE POSITION:

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.

QUALIFICATIONS:

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.

MAJOR RESPONSIBILITIES AND DUTIES:

  • 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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