Senior Medical Writer - Clinical/Regulatory
Job Description
Job Description
EPM Scientific has been partnering up with an oncology-focused biotech company based in the NYC/NJ/SF area that is now looking to bring on a Senior Medical Writer.
The roles/responsibilities will include:
- Writing key clinical and regulatory documents like CSRs, protocols, protocol amendments, IBs, CTDs, briefing documents, abstracts, manuscripts, posters
- Being an oncology subject matter expert
- Working cross-functionally with different teams
A strong candidate for this role will bring:
- Minimum of 3 years of sponsor-side (direct biotech/pharma) clinical and regulatory writing experience
- PhD, PharmD, MD preferred
- Experience writing the above documents (for CTD modules - modules 2.5, 2.7, 5)
- Experience in oncology a must
This position is hybrid in either NJ, NYC or SF!
Reach out or apply now.
Company DescriptionA top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.
Job Responsibilities:
•\tConducting Post Market Activities and Post Market Surveillance
•\tManaging Customer and Product Complaint Investigation programs
Education and Experience:
•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•\tBachelor's degree
•\tComputer proficiency
Company Description
A top 10 pharmaceutical company with an immense amount of growth after releasing their at home COVID diagnostic tests is looking to bring on 200+ Quality Individuals through a massive hiring campaign. In their search for Quality Specialists, the organization is looking for individuals who will be responsible for reviewing and actioning customer complaints, as well as investigation into said complaints.\r\nJob Responsibilities:\r\n•\tConducting Post Market Activities and Post Market Surveillance\r\n•\tManaging Customer and Product Complaint Investigation programs\r\nEducation and Experience:\r\n•\t1 YR. of experience in a technical role in the medical device/pharma/biotech industry\r\n•\tBachelor's degree\r\n•\tComputer proficiency