Key Facts

Remote From:

India

Category: Technical Support Specialist

Full time

English

Hard Skills

Adverse Event Monitoring Academic Writing Brand Management Medical Writing

Other Skills

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Communication
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Teamwork
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Organizational Skills
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Analytical Thinking
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Detail Oriented

Roles & Responsibilities

Degree in life sciences, pharmacy, or a related field, or equivalent experience
Experience in medical writing, MLR review, or medical communications
Strong attention to detail and data verification skills with robust referencing
Familiarity with regulatory guidelines and product labeling in healthcare communications

Requirements:

Cross-check scientific information against cited references to ensure data accuracy and completeness; review/add anchor links to appropriate references and maintain citation consistency
Perform reference QC to ensure reference integrity, propose updates, ensure alignment with latest data and approved product labeling, and flag any off-label communications
Conduct basic/high-level QC of assets (branding, style, format, grammar, spelling, punctuation); review footnotes and terminology for consistency and standardize citation style
Create and maintain accurate documentation and checklists for Asset Technical and MLR Review/Creation in line with local guidelines, practices, and regulations

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

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.

Cross-check scientific information against cited references & ensure data accuracy and completeness
Review/Add Anchor links to appropriate highlighted references (if capacity allows and for markets that already have Reference tagging)
Reference QC: ensure reference integrity, propose update if appropriate, ensure statements are still aligned with latest data (e.g. update to latest KDIGO guide)
Ensure alignment with latest approved product label (local) and flag any off-label communication.
QC Essential Information like ISI, Brand & Generic Names, AE Reporting, etc.
Review Footnote information, Terminology & Citation Style to ensure consistency through-out materials.
Perform basic/high-level QC of asset - Branding, Style, Format, Grammar, Spelling and Punctuation
Quality Check and/or create accurate documentation and checklists for Asset Technical and MLR Review/Creation Based on local guidelines, practices and regulations