Senior safety medical writer

CRI1

2 months ago

The Position

As a Safety Medical Writer at Novo Nordisk, you will:

Be responsible for the preparation of complex aggregate safety reports, Risk Management Plans (RMPs), and responses to Health Authority questions.
Collaborate with cross-functional teams, including Clinical Development and Regulatory Affairs, to ensure high-quality scientific writing and timely reporting of safety data.
Contribute to the evaluation and implementation of changes in local/global guidelines to ensure compliance with internal and external requirements.
Drive process improvement activities, medical writing competency development and skill building across Safety Surveillance Reporting.
Act as an expert for junior team members, share information, and take proactive steps to excel in your role.

Qualifications

We are looking for candidates with the following qualifications:

A master’s degree and/or PhD in Life Sciences (e.g., Pharmacy, Medicine, Veterinary, or Biological), combined with proven experience at least 8+ years working within pharmacovigilance and medical writing.
Excellent analytical competencies and experience in working with large datasets.
Solid understanding of pharmacovigilance and of drug development in general.
Expert understanding of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs) and RMPs, and the guidelines and regulations that drive their preparation.
Fluency in both written and spoken English (business language) and solid experience using MS Office.
Experience in handling documents of high complexity (e.g., submissions of Marketing Authorisation Applications) or prior experience in performing specialist tasks will be considered an advantage.