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Senior Medical Writer

Hyderabad, Telangana, India Date posted 06/28/2019 Job ID 53499BR

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas.

  • Full Time
  • Level: Mid
  • Travel: No
  • Glassdoor Rating 3.5

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Detail-Oriented
  • Deadline-Oriented
  • Communicator
  • Organized
  • Versatile
  • Tech-Savvy
  • "I am part of a great team! My colleagues at Parexel are a pleasure to work with, are
    knowledgeable, experienced, caring and always ready to help!"

    Anne-Christin Friedrich - Senior Medical Writer
  • "I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,
    knowledgeable, and it is easy to communicate with other staff."

    Christine Simmons, Medical Writer II
  • "Parexel makes it easy to communicate and interact with each other, which allows
    me access to expertise and knowledge beyond my own."

    Kristy Haslerud, Associate Manager
  • "Since the day I started, I have learnt something new from people on my team: it can be something associated with medical writing, the latest technology, or a tool that enhances/ aides writing."

    Erangi Tennakoon, Medical Writer II

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Work-life Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Career Development

    Opportunity to learn and grow through a performance and development goal-setting program.

  • Home based

    Love where you work, and work where you love.

  • Variety

    Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

Responsibilities

Preparation of documents such as Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Safety Assessment Reports (SARs), in accordance with client/international conventions.

Qualifications

• Science/Medicine degree: The minimum qualification required would be a University degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
• A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in hospital based environment, would be an advantage
• Should have 3 to 5 years of relevant experience in authoring of aggregates reports (PSURS/PBRERs, DSURs, PADERs, SARs and RMPs). If person has worked on innovator drugs then it would be an advantage
• Good knowledge of medical terminology

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