Job Description

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 based at either our Head Office situated in Uxbridge, Madrid or Dublin or be fullyhome-based anywhere in the UK, Ireland or Spain . The offices are open planned, and you will be working in an innovative and collaborative environment.

As the Medical Writer II you will research, create, edit, andcoordinate the production of clinical documents associated with submissions to regulatory authorities,including but not limited to: study protocols, model informed consents, interim and final clinical studyreports, and safety update reports. The Medical Writer II will also be responsible for the production ofclinical study documentation associated with clinical trials that may not be included in a regulatorysubmission. You may also serve as the primary client contact.

Key Accountabilities:

Author ClinicalDocuments
- Gather, review, analyze, and evaluate pertinent resources to prepare, develop,and finalize clinical documents for submission to regulatory authorities,including but not limited to: study protocols, model informed consents, interimand final clinical study reports, and safety update reports.
- Revise document drafts based on the review comments from team membersto ensure inclusion of all relevant input.
- Follow required standard operating procedures (SOPs), templates, guidelinesregulations, client instructions and other processes, as applicable.
- Perform literature searches/reviews as necessary to obtain backgroundinformation and training for development of documents.

Quality Control
Ensure that all work is complete and of high quality prior to team distribution orshipment to client.
- Confirm data consistency and integrity across the document.
- Prepare documents for publishing readiness, when applicable.
- Ensure document structure, content, and style adheres to FDA/EMA orother appropriate regulatory guidelines, and comply with departmental,corporate or client SOPs and style guidelines, as applicable.
- Provide suggested alternative content when contributors provide contentthat does not meet document needs.
- Provide medical editing review of draft and final documents prepared by otherwriters before internal or external distribution.

DocumentProjectManagement:
- Serve as primary client contact for medical writing projects, negotiatingdeliverable timelines, and resolving project-related issues.
- Serve as the Medical Writing representative on assigned project teams anddemonstrate document leadership, with departmental supervision (if needed): communicate content requirements, coordinate and conduct interdepartmentalteam review of draft and final documents, according to Parexel or clientguidelines/SOPs.
-Distribute final documents to project team and client.

Training/Compliance
- Attend and complete mandatory, corporate, project-specific, and departmentaltraining as required.
- Keep abreast of professional information and technology through workshopsand conferences (when approved), and assure appropriate transfer of thatinformation to the department.Qualifications

Education:
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

Skills:
- Excellent interpersonal, verbal, and written communication skills.
- Ability to consistently produce documents of high quality.
- Demonstrates attention to details and proactivity.
- Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
- A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
- Ability to efficiently manage time spent on tasks and proactively identify deficiency. Managemultiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g.,organizational skills.
- Willingness to work in a matrix environment, values the importance of teamwork, andunderstands roles of other project team members. Possesses team leadership skills and cross-culturalsensitivity.
- Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectationsare aligned.
- Strives to understand and satisfy client needs.
- Gains trust and establish a connection with the client beyond one's project, to gain repeat
business and/or to widen existing scope and services.

Knowledge and Experience:
- Demonstrated understanding of clinical research, the drug development process, and industryguidelines and regulations, e.g., ICH-GCP.
- Extensive previous clinical/scientific medical writing skills performed as a clinical medical writer preferably from the CRO or Pharma industry
- Scientific background essential; writing experience includes multiple clinical study reports.
- Advanced word processing skills, including MS Office (expertise in Word); software and systemsknowledge or ability to learn and adapt to various IT systems: document management systems,collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
- Fluent in written and spoken English with appropriate attention to phraseology, grammar, andpunctuation.
- If required to perform translation work and quality control of documents written in non-Englishlanguage, proficiency in relevant language is a prerequisite.

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, as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.

Apply today to begin your Parexel journey!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.