Lead Clinical Research Scientist

2 weeks ago


Marlborough, Massachusetts, United States Global Channel Management Full time
Position Overview:
Global Channel Management is a leading technology firm focused on recruitment and staff augmentation across various sectors. Our team of account managers and recruiters brings over a decade of expertise in diverse industries.

At GCM, we recognize the complexities organizations encounter in sourcing the necessary skills and experience to effectively manage daily operations.

Companies are tasked with minimizing training and labor expenses while simultaneously attracting top-tier talent.


Qualifications:
The Principal Scientist role requires a minimum of 4-6 years of experience within a pharmaceutical organization or a related field, including at least 2-3 years in clinical safety or regulatory affairs.

Educational Requirements:
A Master’s Degree or PhD in Medical Science, Pharmacy, or Nursing is preferred.

Experience:
Candidates should possess a minimum of 2-3 years of medical writing experience, ideally in drafting pharmaceutical reports such as PSURs, Clinical Study Reports, safety sections of the ISS, or the Common Technical Document. Experience in Medical Surveillance and Risk Management is also beneficial.

Applicants must demonstrate a solid understanding of clinical disease states and treatment implications, as well as proficiency with data and statistical analysis.

Knowledge Requirements:
Familiarity with ICH, US & EU regulations regarding pharmacovigilance, including worldwide safety reporting regulations and guidelines, is essential.


Key Competencies:
  • Clinical Safety
  • Clinical Study
  • Clinical Trial
  • Pharmacovigilance

Responsibilities include collaborating with team members to identify discussion topics for Section 9 and preparing the initial draft for Medical Director review. Additionally, follow-up on issues highlighted in regulatory responses, such as assessment reports, is required.


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