Medical Device Regulatory jobs

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as PK Scientist II for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

RESPONSIBILITIES

Conduct PK/PD data analysis using non-compartmental analysis. May also provide support in the conduct of PK/PD modeling and simulations (individual and population) using software such as Phoenix® WinNonlin® and Non-linear Mixed Effect (NLME), Monolix, and R, etc.

Apply learned experiences and knowledge to more complex tasks as assigned.

Apply strategic direction and vision on PK/PD data analysis to support clinical trial designs, compound development plans, and regulatory submissions.

Generate predictive simulations and provide input into trial protocol development.

Provide input into clinical trial Statistical Analysis Plans (and mock tables, listings, and graphs [TLGs] shells) including PK/PD analysis components or author standalone PK/PD Analysis Plans (including PK/PD mock shells).

Author and/or review PK/PD related documents or reports such as protocols, PK Study Reports, ensuring appropriate and accurate interpretation of PK and PK/PD-related study endpoints.

Contribute to the clinical pharmacology sections of relevant documents, such as clinical study protocols, clinical study reports, Investigator's Brochures, briefing documents, and Investigational New Drug (IND)/New Drug Application (NDA) and/or Abbreviated New Drug Application (ANDA) submissions.

May work with regulatory affairs personnel to provide PK/PD data in support of regulatory communications and presentations as needed.

Participate in the maintenance of, and adhere to, divisional Standard Operating Procedures (SOPs) and guidelines, and to therapeutic area specific standards and conventions.

Keep current with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.

Plan and carry out professional development.

REQUIREMENTS

Advanced degree, Ph.D., or M.Sc. in Clinical Pharmacology (including Pharmacokinetics, Pharmacodynamics), Pharmacy, Biopharmaceutics, or related field.

At least 2 to 4 years’ experience as a PK Scientist or related role in the pharmaceutical clinical trial environment.

Experience in multiple therapeutic areas and Phase I through IV clinical trials is preferred.

Proficient in using WinNonlin, or equivalent; other relevant pharmacometric software for non‑compartmental analysis, PK/PD analysis, and modeling is preferred.

Familiarity with SAS and/or R is preferred (or willingness to learn and master SAS skills).

Excellent understanding of clinical trials and common clinical trial statistical analysis methods is preferred.

Skilled in scientific writing and data interpretation is preferred.

Demonstrated ability to understand PK results; able to communicate effectively, orally and in writing.

Demonstrated ability for logical thinking, vision, and creativity necessary to function effectively with a large degree of independence and little supervision.

Experience with client relationship management preferred.

Ability to multi-task, manage multiple projects with competing and aggressive timelines.

Excellent interpersonal and teamwork skills; detail-oriented, customer-, and quality-focused.

Well organized and able to work independently.

Strong understanding of fundamental PK/PD and statistical principles.

Everest is inviting candidates to apply to this existing vacancy.

Benefits & Compensation:

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $105,000 - $120,000.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com (http://www.ecrscorp.com).

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.

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