Transparency and Disclosure Specialist - Serbia - Remote

Posted Yesterday
Be an Early Applicant
Hiring Remotely in Serbia
Remote
Mid level
Biotech • Pharmaceutical
The Role
Manage transparency and redaction for clinical documents, prepare submission-ready documents for public release, and enhance process through improvements.
Summary Generated by Built In

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

What Medical Writing department does at Worldwide

Medical Writing at Worldwide is a dynamic global group with comprehensive peer, leadership and administrative support. Our team liaises with Subject Matter Experts across the company, including regulatory strategists and clinical methodologists in high level protocol and clinical development discussions. We also author a wide range of documents across many therapeutic areas. Join us and discover opportunities for ongoing training and career development. 

What you will do

  • Managing and coordinating transparency, anonymization and redaction activities for clinical documents and process submissions
  •  Responsible for preparing submission-ready documents to CTIS and any other publicly available portal.
  • Responsible for redaction and anonymization of all submission documents for public release
  • Contributes to process improvement by refining work instructions, training materials and procedures as needed

What you will bring to the role

  • Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner.
  • Project/time management and organizational skills, as well as the ability to work independently.
  • Understanding of global transparency and disclosure requirements; excellent understanding of all aspects of ICH- GCP, FDA, EMA (CTR and Clinical Trial Information System).
  • Attention to detail - style, consistency, grammar, syntax and scientific accuracy.

Your experience

  • University/college degree.
    Prior clinical trial, clinical trial regulatory, privacy or pharmaceutical industry experience or equivalent.

We love knowing that someone is going to have a better life because of the work we do. 

To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

Top Skills

Ctis
Ema
Fda
Ich-Gcp
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Research Triangle Park, NC
2,566 Employees

What We Do

About Worldwide Clinical Trials 

Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing bioanalytical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries.  

Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. Operating in 60+ countries with offices in North and South America, Eastern and Western Europe, and Asia, Worldwide is powered by its more than 3,000 employee experts.  

For more information, please visit www.worldwide.com or connect with us on Twitter, LinkedIn, Facebook, and Instagram.

Similar Jobs

Academia.edu Logo Academia.edu

Peer Review Assistant

Consumer Web • Digital Media • Edtech • Information Technology • Social Impact • Software
Remote or Hybrid
Belgrade, Grad Beograd, Centralna Srbija, SRB

WeLocalize Logo WeLocalize

Shape the Future of AI — Serbian Talent Hub

Machine Learning • Natural Language Processing
In-Office or Remote
35 Locations

Provectus Logo Provectus

Senior Python Engineer

Artificial Intelligence • Information Technology • Consulting
Remote
2 Locations

Perplexity Logo Perplexity

Product Manager

Artificial Intelligence • Software
In-Office or Remote
3 Locations

Similar Companies Hiring

SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Pharmaceutical • Natural Language Processing • Machine Learning • Healthtech • Biotech • Artificial Intelligence
New York, NY
121990 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
51000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account