Regulatory Medical Writing Publishing, Sponsor-dedicated, Europe

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Regulatory eCTD Publishing Specialist, Sponsor-dedicated, Europe
LOCATIONS

• This is a full-time, permanent job opportunity.
• The ideal locations include UK, Spain, Germany, and France.

WHAT YOU WILL DO
You will be one of the primary Regulatory Medical Writing publishers for eCTD submissions, driving the compilation and publishing of high-complexity Phase II-IV clinical regulatory documents, in a team embedded in one of the world’s leading pharma companies.
You will have 3 main areas of focus:

• Working closely with a globally diverse team, to compile and publish clinical documents in eCTD format .
  
• Coordinate and ensure quality of clinical study report appendices.
  
• Perform electronic quality control on clinical documents
  

The essence of the job includes compiling and publishing essential regulatory documents in accordance with appropriate style guides and standards for international regulatory agencies (FDA, EMA, etc.). This job requires a methodical approach to regulatory submission standards which includes hyperlinking, bookmarking, and margins and headers.
YOUR EXPERIENCE

• Master of science degree or bachelor degree in a biomedical, life sciences, or related discipline.
• Minimum 2 years of publishing experience in a Medical Writing or clinical department, either in a CRO, Pharma or Biotech environments.
• Advanced experience with MS Office suite, especially Word processing skills (macros, templates, etc.) as well as Adobe Acrobat/DXC.

PERSONAL/TEAM SKILLS
You´ll be the nexus where multiple teams´ expertise converge. You will leverage your experience to manage compiling projects, publishing projects, setting priorities, and ensuring deadlines are accomplished. We´ll trust you to:

• closely monitor study progress against plan and budget,
• identify any significant variance and recommend actions to implement if timelines are not on target.

To drive publishing of this scale forward, this role requires visibility, proactivity, and excellent communication skills. You must be comfortable navigating sudden change (of priorities and deadlines), managing complex regulatory documents, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience.
Integration within the client´s team is crucial, requiring readiness to assume augmented responsibilities and adaptability across environments and therapeutic areas.
A UNIQUELY DIVERSE CAREER
At Fortrea, we empower you to shape your own career path.
Whether you are passionate about the Medical Writing scientific side, or aspire to be in leadership roles, we provide comprehensive training, management support, a network of SME’s and KOL’s and opportunities to help you thrive.
Your aspirations drive your journey with us. Where do you see yourself?
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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