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Associate / Medical Director, Clinical Neurosciences

5+ years
Not Disclosed
10 July 29, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Parexel: Where Values and Science Meet

At Parexel, we are united by a shared mission: to enhance global health. From clinical trials to regulatory, consulting, and market access, our work is driven by a deep conviction in our purpose. Every member of our team, regardless of their role, contributes to the development of therapies that ultimately benefit patients. We approach our work with empathy and a personal commitment to making a difference.

About Parexel's Clinical Neurosciences (CNS) Team

Parexel’s Medical Sciences team provides an opportunity to deepen your understanding of diseases and the drug development process. Here, you'll learn from colleagues across various specializations and gain insight into how medical practices differ internationally. We pride ourselves on a collaborative environment where knowledge is shared freely, leading to the development of successful treatments that can change patients' lives. Our work spans dozens of therapeutic areas, offering exposure to both top pharmaceutical companies and emerging biotech firms. You’ll work on cutting-edge science, tackling challenging questions about common and rare diseases. At Parexel, you’ll find a supportive, multicultural team environment that promotes work-life balance and provides the flexibility and control you may not find in clinical or academic settings. Join us to make a global impact on health, far beyond the scope of individual efforts.

Position: Associate / Medical Director

Role Overview

As an Associate or Medical Director at Parexel, you will provide essential medical monitoring for assigned projects, serve as a medical representative on project teams, offer medical consultation to clients/sponsors, and sometimes take on the role of Senior Technical Lead. Your responsibilities will include delivering all required medical support to ensure the successful delivery of projects in line with sponsor agreements, reviewing adverse experience reports, and ensuring compliance with FDA and sponsor reporting requirements. You'll also play a crucial role in reviewing safety data, adverse event coding, and providing medical expertise in various client interactions.

Key Responsibilities

  • Independently provide all medical support for project delivery according to contract agreements.
  • Review adverse experience reports for accuracy, clinical importance, and relationship to the study drug.
  • Submit reports to regulatory agencies and sponsors, summarizing adverse experiences.
  • Analyze safety data to identify trends, collaborating with project teams and regulatory bodies as needed.
  • Review documents from various Parexel divisions for safety concerns.
  • Ensure accurate coding of adverse events and concomitant medications.
  • Offer medical expertise in client bid pursuits and proposal development.
  • Consult on protocol development and drug development programs.
  • Provide training and medical expertise to colleagues.
  • Contribute to the preparation of clinical documents, publications, and other materials for clients.
  • Engage in activities to enhance Parexel’s medical expertise both internally and externally.
  • Support Business Development as needed.

Qualifications

  • Medical degree with successful completion of training from an accredited medical school.
  • US Board-certified (or Canadian equivalent) in Neurology, with extensive experience in neurocognitive disorders like Alzheimer's.
  • Experience in adult clinical trials, with the potential to support pediatric trials as needed.
  • Previous experience as a physician in industry or clinical trial investigator is preferred, but strong candidates with a keen interest in clinical trials will also be considered.
  • Exceptional interpersonal, time management, and communication skills.
  • Proficiency in written and spoken English.
  • A flexible and enthusiastic attitude towards new assignments and learning.
  • Ability to prioritize workload and attention to detail.
  • Willingness to work in a matrix environment and value teamwork.
  • Up to 15% domestic and/or international travel may be required.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status in the U.S.