Search TSR Jobs

About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Associate Director

Job Description

  • Location: Lawrence Township, NJ
  • Type: Contract
  • Job #70382

Our client, a leading pharmaceutical company, is hiring an Associate Director on a contract basis.

Work Location

Lawrence Township, NJ/Hybrid

Summary

• Solid scientific background, Ph.D., M.D., PharmD, MS, or BS

• 5 years of experience in Regulatory Affairs- Precision Medicine or Digital Health

• Proven track record in supporting at 3 prior Precision Medicine or Digital Health projects

 

Responsibilities

• Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas.

• Provides innovative approaches to resolve complex regulatory issues and increase speed to patients.

• Ensure global regulatory plans support a precision medicine approach e.g. integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies.

• Ensure high quality collaboration global regulatory leads and provides guidance to the regional strategists and collaborates in strategic meetings with health authorities.

• Represents client in key interactions with Health Authorities

• Provide strategic input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug, diagnostic, and digital health products.

• Ensure high quality collaboration with Precision Medicine/Digital Health teams to development of companion diagnostic, digital health tools and other device to optimize access to patients.

• Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence and is viewed as an expert in its application to the regulatory process.

• Provides guidance on planning, writing, review of key dossier documents for submissions globally.

• Ensure Global Regulatory Science and Policy representation as needed in governance or strategic teams or committees.

• To ensure compliance of client programs with regulatory requirements for diagnostics and devices.

• Provides ongoing feedback and accountable for coaching, and career development to staff in order to maximize their potential.

 

Required

• Scientific background, Ph.D., M.D., PharmD, MS, or BS

• Significant experience in regulation of diagnostic/digital health devices

• Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of device clinical trial application submissions and approvals in US and EU/UK

• Understanding of policy, laws, regulations and guidelines as they apply to Regulatory Agencies globally for diagnostic/digital health tool development and approval with particular focus on US and EU/UK

• Experience of drug development and drug regulatory procedures.

• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the drug and device development and commercialization process.

• Good interpersonal skills; willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.

• Experience in successfully leading teams; Demonstrated ability to drive quality decision-making. Demonstrated ability to organize / prioritize tasks.

• Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.

• Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.

• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.

• Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.

• Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.

• Experience as a member of global regulatory subteam, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).

• Experience utilizing leadership techniques to drive a team through the stages of team development.

• Proven ability to coach and mentor other leaders as a coach, while being an individual contributor to projects.

• Successful track record of leading through influence and working across complex, global organizational matrices.

Other Qualifications

• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional and geographic boundaries to achieve company goals.

• Communicates opinions, facts and thoughts with clarity, transparency and honesty

• Sets clear and high expectations and holds self and others accountable for decisions and results achieved.

• Seeks multiple perspectives and listens openly to others points of views.

• Enables and demonstrates the courage to speak up on issues and risks as well as on the good news.

• Demonstrates ownership of results within (and beyond) area of responsibility.

• Looks for opportunities for continuous improvement.

 

 

Include a message to the recruiters.
Attach a resume file. Accepted file types are DOC, DOCX, PDF, HTML, and TXT.

We are uploading your application. It may take a few moments to read your resume. Please wait!