Drug Safety Medical Writer
Hydrogen Group, Trenton, NJ, United States
Consultant Medical Writer (Drug Safety / Pharmacovigilance)
Contract | Variable Hours (Approx. 15-40 hours/week)
Overview We are seeking an experienced Consultant Medical Writer to support our Drug Safety and Pharmacovigilance (PV) function. This role focuses on the development of safety- and PV‑related documents and content, working closely with cross‑functional teams to ensure high‑quality, accurate deliverables.
This is a flexible, contract‑based role with variable hours, typically ranging from 15 to 40 hours per week.
Key Responsibilities
Author and contribute to drug safety and pharmacovigilance documentation, including safety sections of regulatory and non‑regulatory documents
Collaborate with Drug Safety/PV teams to interpret and present safety data clearly and accurately
Support the preparation of safety narratives, reports, and other PV‑related materials
Ensure consistency, scientific accuracy, and clarity across all written deliverables
Adhere to internal standards, timelines, and quality expectations
Ideal Candidate Profile
Background in Pharmacovigilance, Drug Safety, or Pharmacokinetics (PK/PV)
Experience in medical writing with a focus on safety content, either in‑house or as an independent consultant
May come from a Drug Safety/PV operational role with strong writing expertise and interest
Prior experience specifically in regulatory document writing (e.g., protocols, IBs, CSRs) is not required
Skills & Competencies
Strong scientific writing and data interpretation skills, particularly in safety contexts
High attention to detail and ability to communicate complex information clearly
Reliable, responsive, and able to work independently in a remote/consulting environment
Effective communicator with collaborative mindset
Technical & Logistical Requirements
Access to a Windows‑based laptop and familiarity with Microsoft Office tools
Comfortable using standard business and document management systems
Ability to integrate into an existing team structure and workflows
Additional Notes
This role follows the same structure and expectations as other consultant medical writers within the organization
Successful candidates will demonstrate performance aligned with high‑performing peers in similar writing roles
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Contract | Variable Hours (Approx. 15-40 hours/week)
Overview We are seeking an experienced Consultant Medical Writer to support our Drug Safety and Pharmacovigilance (PV) function. This role focuses on the development of safety- and PV‑related documents and content, working closely with cross‑functional teams to ensure high‑quality, accurate deliverables.
This is a flexible, contract‑based role with variable hours, typically ranging from 15 to 40 hours per week.
Key Responsibilities
Author and contribute to drug safety and pharmacovigilance documentation, including safety sections of regulatory and non‑regulatory documents
Collaborate with Drug Safety/PV teams to interpret and present safety data clearly and accurately
Support the preparation of safety narratives, reports, and other PV‑related materials
Ensure consistency, scientific accuracy, and clarity across all written deliverables
Adhere to internal standards, timelines, and quality expectations
Ideal Candidate Profile
Background in Pharmacovigilance, Drug Safety, or Pharmacokinetics (PK/PV)
Experience in medical writing with a focus on safety content, either in‑house or as an independent consultant
May come from a Drug Safety/PV operational role with strong writing expertise and interest
Prior experience specifically in regulatory document writing (e.g., protocols, IBs, CSRs) is not required
Skills & Competencies
Strong scientific writing and data interpretation skills, particularly in safety contexts
High attention to detail and ability to communicate complex information clearly
Reliable, responsive, and able to work independently in a remote/consulting environment
Effective communicator with collaborative mindset
Technical & Logistical Requirements
Access to a Windows‑based laptop and familiarity with Microsoft Office tools
Comfortable using standard business and document management systems
Ability to integrate into an existing team structure and workflows
Additional Notes
This role follows the same structure and expectations as other consultant medical writers within the organization
Successful candidates will demonstrate performance aligned with high‑performing peers in similar writing roles
#J-18808-Ljbffr