Documentation Specialist / Medical Writer - FSP

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

About Parexel

Parexel is a leading global clinical development partner delivering insights driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose, moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart®.

About the Role

We are seeking a Documentation Specialist / Medical Writer to join our team in Poland, Spain, Romania, or Serbia.

As a Documentation Specialist / Medical Writer, you will serve as a dedicated, embedded resource supporting the development of high quality clinical and regulatory documents. This role plays an important part in advancing clinical research by ensuring the timely preparation, coordination, review, and finalization of key clinical documents, including Clinical Trial Reports (CTRs), Clinical Trial Protocols (CTPs), protocol amendments, Investigator's Brochures (IBs), biomarker reports, and submission related documentation.

You will work closely with cross functional project teams, participate in planning and alignment activities, manage document timelines, coordinate review cycles, and support quality and compliance processes throughout the document lifecycle. Responsibilities include clinical document development, document management within electronic document management systems, stakeholder coordination, quality control oversight, and support for document approval and publishing activities.

You will join a fast paced, growth oriented environment where your expertise contributes directly to the delivery of clinical research programs and the advancement of new therapies for patients. Working as an integrated member of the team, you will have the opportunity to deepen your knowledge of clinical development processes while helping ensure the successful execution of critical study and submission milestones.

Key Responsibilities

• Develop and maintain clinical and regulatory documents including CTRs, CTPs, protocol amendments, IBs, biomarker reports, and submission documents

• Manage clinical documents within the Electronic Document Management System (EDMS), including document setup, workflow management, and approvals

• Establish, communicate, and maintain agreed project timelines in collaboration with trial and project teams

• Prepare for, facilitate, and document project meetings, kick off meetings, Results Alignment Meetings, trial team meetings, and submission meetings as required

• Draft clinical documents, including appropriate in text tables and figures, in accordance with agreed timelines and applicable procedures

• Coordinate and manage document review cycles, drive alignment on comments, integrate revisions, and complete required review documentation

• Initiate, conduct, or oversee quality control activities and complete supporting quality control documentation

• Finalize and deliver completed documents to project teams and support document publishing and pre archive activities

• Perform technical and formatting checks for Investigator's Brochures and related updates

• Support final electronic approval processes and ensure compliance with established procedures, systems, and standard operating procedures

• Collaborate effectively within an integrated team environment and participate in ongoing project governance, feedback, and alignment activities

Candidate Profile

You'll thrive in this role if you bring:

• Experience with technical writing or medical writing

• Experience working in clinical research or another regulated environment

• The ability to collaborate across teams and communicate clearly with a variety of stakeholders

• A quality focused mindset and strong attention to detail

• Comfort working with electronic document management systems, document review processes, and quality control procedures

Required Qualifications

• Bachelor's degree or equivalent combination of education and relevant experience

• Knowledge of clinical development documentation processes and regulated working environments

• Experience working with Electronic Document Management Systems (EDMS) and document lifecycle management processes

• Strong communication, organization, stakeholder management, and problem solving skills

Preferred Qualifications

• Advanced scientific, life sciences, or related educational background

• Experience supporting clinical trial documentation and regulatory submissions

• Familiarity with clinical document review, quality control, publishing, and approval workflows

• Experience collaborating within cross functional clinical development teams

Originally posted on Himalayas