Expiry Date: 31-07-2023
Category Regulatory Affairs
Job Type: Full Time
Are you an innovative medical writer seeking an opportunity to lead a growing team and help drive collaboration within existing teams, stakeholders, and regulatory authorities?
Then you will be excited to hear that our team and I are helping a smaller biotech find someone experienced in providing strategic input to become their new Lead Medical Writer at an Associate Director grade.
About the organization:
Our client has an impressive market cap, great data readout, and a warm and friendly work environment, where you get to exchange creative ideas and benefit from the know-how of all senior executives. The executive team is made up of skilled industry leaders with proven track records in their respective fields of therapy.
The company focuses on cell and gene products targeting indications in rare diseases. They really enjoy working with passionate and likeminded people, which is why it will not take you long to feel at home and to see your contributions being recognized, appreciated and rewarded.
The person you will be reporting to for this position has two decades worth of experience excelling at various roles in regulatory strategy, across a variety of therapy areas. She has made significant contributions to the development and filing of several products and she is an encouraging leader who has advanced investigational drugs through all phases.
- You will be skilled in planning, resourcing, and executing all Medical Writing activities in compliance with SOPs, regulations, development needs and timelines
- You will be experienced in providing leadership, oversight and strategic direction to the medical writing function including developing the people and the function to anticipate and meet business needs
- You will possess extensive experience in writing documents for submission to the regulatory agencies, including clinical study reports, investigator’s brochures, clinical summary documents, clinical trial protocols and regulatory query responses
- You will be a detail-oriented, energetic, and self-motivated professional who can manage abstracts, patents, reports, IND, BLA, and NDA filings for multiple submissions
- You will initially focus early dev guiding the programs through to initial NDA
- You will handle both regulatory writing and clinical writing, with a solid amount of strategic input where you will take matters into your hands, and will always be supported and encouraged by the existing executive leadership.
About the offer:
- The company can offer a very competitive salary, as well as a significant stock and bonus plan
- The role is also fully remote, so you can work from anywhere in the US on EST hours.
If you are interested in hearing more about this or other roles in Medical Writing, please contact me, Theo Moore on 587.216.9302 or via email Theo@Advtalent.com, or my colleague Ivan Nash on +1-908-378-8980.