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Associate Director, Clinical Affairs

Zenith LifeScience

This is a Contract position in South Brunswick, NJ posted March 25, 2020.

The Associate Director, Clinical Affairs is responsible for the development and management of the clinical affairs function (in the Medical Affairs Department) in support of the company product development and assures compliance with applicable regulations regarding all pre-market and post-market product clinical study activities as defined within company procedures.

Provides strategic direction for clinical evaluation of products in support of regulatory approval and marketing needs.

SME in Clinical Affairs management and execution.

Job Descriptions:
•Utilize technical clinical affairs skills to propose strategies on complex issues.

•Provide clinical input to product lifecycle planning.

•Provide strategic input and technical guidance on clinical requirements to development teams.

•Manage and execute pre-approval clinical activities.

•Monitor impact of changing regulations on submission strategies and update internal stakeholders.

•Support and review regulatory submissions as required.

•Contribute to applicable submissions (IDE, PMA, CER, etc.), reports and responses to regulatory authorities.

•Ensure compliance with product post-marketing approval requirements.

•Establish and maintain relationships with alliance partners, external companies, investigators and key opinion leaders to optimize performance on clinical trial activities.

•Review and approve required reports, supplemental submissions and other post-marketing commitments to update and maintain product approvals and registrations.

•Provide training for stakeholders on current and new clinical requirements to ensure company-wide compliance.

•Develop and maintain ClinicalTrials.gov responsibilities for the business unit products.

•Develop and maintain business unit SOPs/processes for clinical research.

•Interface with Corporate Medical Affairs on developing processes and internal standards.

Qualifications:
•Minimum M.S.

Science, engineering, or other relevant technical degree with minimum 10 years of leadership experience in clinical affairs.

Advanced degree (e.g.

MPH, PhD) strongly preferred.

•Good knowledge and experience with clinical affairs regulations and implementation.

•Will manage multiple parallel studies from initiation through completion with resulting successful marketing authorization, publications, and establishment of broadened indications and claims for medical devices.

•Good knowledge of medical products quality system principles and GCP concepts, practices and procedures.

•Able to work independently with confidence, resolve conflicts, and negotiate with a “win-win” approach.

•Able to work in a matrix/team environment with prior significant experience supervising regulatory affairs professionals.

•Ability to travel.