Job Description

We are currently looking for a number of Regulatory Clinical Writers on various levels, ideally with experience working in the vaccine/ biologics area. This position is open in various European locations - office or home- based.
This is a fantastic opportunity to partner with a key client in biopharma industry!

Key responsibilities:

Develop regulatory plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects

Collaborate with Global RA Clinical Lead and/or Regional RA Clinical lead to provide regulatory support for assigned projects

Communicate with Regulatory Operations on the planning of marketing applications, post-approval supplements and variations

Contribute to the development of and to the definition of the Clinical content requirements for strategies for timely approval of regulatory filings throughout the product life cycle

Authoring clinical sections of regulatory files, life cycle variations/supplements for all destinations, including - CTD Modules 2 & 5,- Responses to Questions raised by Regulatory Authorities on clinical, epidemiological, and safety matters- Briefing documents for regulatory consultations- pediatric investigation plan (PIP)/pediatric study plan (PSP)

Ensure the coordination with the departments involved in the writing/review process)

Prepare and coordinate the review and approval of submission-ready documents

Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations

Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copy/editing check

Work collaboratively with Clinical Writing colleagues and SMEs to interpret and summarize complex data

Qualifications

Skills and Experience required for the role:

BA/BS in scientific or technical discipline or advanced degree

At least 3-5 years of bio-pharmaceutical regulatory /clinical writing experience

Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance

Experience preparing Clinical sections of INDs, CTAs, NDAs, BLAs, MAAs and supportive amendments and supplements (ICH Modules 2 and 5)

Strong problem solving and diplomacy skills

Exposure to regulatory requirements for vaccines/biologic product development is highly desired

Excellent project management skills

Fluent English

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.