Job Description

Job Title:

Quality Control Specialist (Medical Writer)

Location:

India

Type:

Remote or hybrid

About the Job

Join Excelya, where

Audacity, Care, and Energy

define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs and Writing. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities:

To review and edit medical writing and clinical regulatory documents (including, but not limited to clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, common technical document submissions, Investigator Brochures, Lay Summaries as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) according to the sponsors' and Excelya's SOPs. To perform quality control activities, ensuring the accuracy of all information, data, and references for the documents/tables/figures/listings produced, also reviewing spelling, grammar, appropriateness of language, correct mention of links to other part of the document or other documents, and compliance to industry guidelines. To check information in the document against the data source (internal consistency within a document and across documents). To deliver documented quality review comments or checklists to the document's author through resolution, while interacting with the Medical Writers and other team members to resolve QC findings.

About you:

At Excelya,

taking audacious steps is encouraged

, so we're looking for individuals who are ready to grow with us and share our values.

Experience

: Relative experience 1-5 years as a QC Specialist/Editor, Copyeditor, or Medical Writer of clinical regulatory documents (such as clinical study reports, protocols) is considered a plus.

Skills

: Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines, Analytical skills and ability to interpret data, Attention to detail, A strong work ethic, Intellectual curiosity and creativity, The ability to work effectively in a team in a fast-paced and dynamic environment.

Education

: University graduate in life sciences or equivalent (post-graduate studies in a relative field are considered a plus).

Languages

: Advanced level of English, both written and verbal.

Why Join Us?

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.



Here's what makes us unique--



We are a young, ambitious health company representing 900 Excelyates, driven to become Europe's

leading mid-size CRO

with the

best employee experience

. Our

one-stop provider service model

--offering full-service, functional service provider, and consulting--enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient's journey.

Excelling with care

means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.

Excelling with Care

At Excelya,

Care

lies at the heart of what we do. We provide equal opportunities for all and foster a diverse, equitable, and inclusive workplace where humility and boldness work hand in hand. Everyone has a space to feel valued, thrive, and collaborate with purpose.

Your challenges become our shared mission. Together, we transform bold ideas into reality--the Excelya way.

Apply today, become an Excelyate!

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Summary

Type of job:
full time
Location:
India
Capability:
Medical Writing & Publishing


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Contact

Athina Bara

International Talent Acquisition Officer