R&d Document Associate

5 days ago

Melbourne, Australia Bell People Consultants Full time

Leading Pharmaceutical Global Manufacturing Organisation
- Virology Background highly desirable
- Melbourne Metropolitan Area - Long Term contract

**About the company**:
Operating as a leading global pharmaceutical manufacturing organisation with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace, offering a range of healthcare products to local & global markets.

Due to increase in requirements within the R&D Group, an opportunity has now arisen for a **R&D Scientist Document Associate** with a** Virology background** to provide support in preparing regulatory documentation for global product portfolio including developmental to commercial phases of products lifecycle.

**About the Opportunity**:
Key responsibilities include the following:

- Create templates for study & regulatory documentation for CMC dossier, R&D reports.
- Generate technical reports for regulatory submissions & prepare regulatory CMC sections.
- Prepare regulatory CMC sections including developmental to commercial phases of products lifecycle.
- Draft SOP, policy & work instruction documents for R&D department.
- Monitor regulatory developments & advise management/key stakeholders on the potential impact of regulations on the organization.

**About You**:

- Bachelor degree or post graduate degree in Life Sciences.
- Sound industry experience in pharmaceutical, medical device, biotech.
- Minimum 3 years regulatory experience in the pharmaceutical industry.
- **Virology background highly desirable.**:

- **Strong scientific technical writing skills.**:

- Demonstrated ability to work across sites and across international teams.
- Excellent interpersonal & communication skills.
- Strong relationship building skills & the ability to influence key global stakeholders.

**Culture & Benefits**

This is an **excellent long term contract opportunity** for a R&D Scientist Document Associate with a** Virology background** to join a global pharmaceutical organisation & be involved in **scientific regulatory documentation work on a global scale.**

**How to Apply**

For confidential discussion, please contact Sue Campbell on 0417 994 917 or Maria Julienne on 0491 694 371.

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