Regulatory Affairs Associate - Clinical Writer

Parexel International Corporation

Lithuania - Any Region - Home Based

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

This role can be either office based in Uxbridge or Dublin or you can be fully home based anywhere in the UK or Ireland respectively. The offices are open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. This role can also be office based or home based in the following countries: Hungary, Belgium, Italy, Spain, Lithuania , Poland, Sweden, Norway, Finland, Denmark Czech Republic , Croatia or Romania.

As the Regulatory Affairs Consultant (Clinical Writing) you will have an understanding of the organization’s consulting models and methodologies, as well as a good knowledge of what services the group provides. You must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market. You will also ensure the timely performance of work within a project scope to the quality expectations of the group and the client.

This Regulatory Affairs Consultant (Clinical Writing) position will specifically focus on authoring Clinical Overviews (CTD Module 2.5) and Clinical Summaries (CTD Module 2.7); Preparing CTD modules 4 and 5; authoring clinical sections of regulatory documentations (IMPDs, Scientific Advice Briefing Documents, Investigator Brochures, Pediatric Investigation Plans, Orphan Designation Applications, etc).

Key Accountabilities:

Project Execution

- Typically works within a team environment but may work independently delivering services within their technical area of expertise

- Works within broad project guidelines but liaises closely with more senior colleagues to discuss issues and resolve conflicts

- Demonstrates ability to prioritize work and define steps needed to achieve specified project outcomes

Consulting Activities and Relationship Management

- Follows and implements the organization’s consulting models and methodologies

- Provides technical and/or business consulting services within personal area of expertise

- Completes assigned activities within project scope and objectives with an understanding of issues which may impact project profitability

- Collaborates with colleagues and client to identify and resolve technical and process issues

Business Development

- Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience

- Communicates potential new business leads to PC management and account managers

- May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

Parexel related responsibilities

- Meets established metrics as specified in scorecard on an annual basis

- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management. QualificationsEducation:-

Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced degree preferred;


- Project management knowledge

- Clinical Writing skills

- Client-focused approach to work

- Results orientation

- Teamwork and collaboration skills

- Consulting skills

- Excellent interpersonal and intercultural communication skills, both written and verbal

- Critical thinking and problem-solving skills

- Proficiency in local language and extensive working knowledge of the English language

Essential Skills and Experience:

- Previous experience working in a CRO, Pharma or a Regulatory agency in the capacity as a Regulatory Clinical Writer, Regulatory Affairs Consultant or Senior Regulatory Affairs Associate with a a keen desire and focus on Clinical Writing .

- Experience authorising regulatory documents or writing in peer reviewed journals;

- Several years of experience in an industry-related environment preferred;

- Experience with safety reports (DSUR, PSUR) is desirable;

- Critical thinking and problem-solving skills;

- Ability to summarize regulatory guidelines and apply them appropriately;

- Ability to understand and interpret clinical data from different sources;

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!


2022-08-03 00:05:20

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