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    Medical Writer Ii

    Parexel
    2+ years
    Not Disclosed
    Mohali
    10 Dec. 27, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills:

    Job Title: Medical Writer

    Department: Medical Writing
    Location: Remote

    About Parexel:

    As a Medical Writer at Parexel, you will be at the forefront of transforming complex scientific data into clear, coherent documents that effectively communicate critical information to various stakeholders, including regulatory agencies, healthcare professionals, and the general public. Your ability to collaborate with cross-functional teams will be key to developing essential clinical research documents such as clinical study reports (CSRs), informed consent forms, pharmacovigilance documents, and more.

    We pride ourselves on fostering a culture of inclusivity, collaboration, and support, empowering our employees to make a meaningful impact on people’s lives. Parexel offers continuous learning opportunities, from mentoring to job rotation, and supports your career development and promotion based on both global standards and your personal development goals.

    Success Profile:

    We are looking for individuals who possess the following traits and soft skills to thrive in this role:

    • Adaptable
    • Communicator
    • Consistent
    • Deadline-oriented
    • Detail-oriented
    • Insightful

    Key Responsibilities:

    Aggregate Reports:

    • Report Preparation and Management: Oversee the preparation, updating, and merging of Risk Management Plans (RMPs) and Company Core-RMPs (CC-RMPs). Manage the creation and submission of various safety reports, including PSURs, PBRERs, DSURs, PADERs, and more, ensuring compliance with client and regulatory requirements.
    • Safety Data Analysis: Conduct critical appraisals of literature and epidemiology data to support background rates in safety reports. Generate line listings and ensure consistency across documents.
    • Quality Control: Perform quality reviews on aggregate reports, verifying accuracy, consistency, and compliance with internal and regulatory standards.

    Clinical Study Report (CSR) Narratives:

    • Narrative Development: Collaborate with study teams to draft clear and accurate narratives based on clinical and safety databases. Ensure that narratives adhere to client conventions and Parexel's guidelines.
    • Review and Quality Assurance: Perform quality checks on drafted narratives to ensure completeness, cohesiveness, and adherence to regulatory standards.

    Signal Detection and Management:

    • Signal Detection: Analyze safety data from multiple sources (e.g., regulatory databases, client databases, literature) to identify potential signals.
    • Signal Management: Lead the end-to-end signal management process, including signal tracking, assessment, and data analysis, and collaborate with the Global Safety Operations (GSO) team.

    General Responsibilities:

    • Regulatory Compliance: Ensure all documentation and submissions comply with relevant regulations and client requirements. Maintain an awareness of global regulatory reporting obligations.
    • Client Liaison: Act as the primary contact for clients, managing expectations, resolving issues, and ensuring high-quality work is delivered on time.
    • Team Collaboration: Support internal teams by mentoring new recruits, conducting project-specific training, and contributing to departmental initiatives.

    Skills & Qualifications:

    Key Skills:

    • Medical Writing: Proficient in writing unambiguous medical text and creating concise synopses of complex data.
    • Analytical & Problem-Solving: Strong ability to analyze data, draw conclusions, and solve problems independently.
    • Communication: Excellent verbal and written communication skills with the ability to effectively convey complex scientific information.
    • Collaboration & Teamwork: Able to work collaboratively with cross-functional teams and clients in a dynamic environment.
    • Attention to Detail: Ensure accuracy and completeness in all work, maintaining high standards of quality.

    Experience:

    • Experience in regulatory writing, pharmacovigilance, or a related field.
    • Familiarity with clinical study reports, safety reports, and risk management documentation.
    • Experience in signal detection and safety data analysis is a plus.

    Education:

    • Science/Medicine Degree: A minimum of a university degree in life sciences, health, or biomedical sciences (e.g., pharmacy, microbiology, biochemistry, biotechnology, biophysics).
    • A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is advantageous.

    Additional Information:

    • Remote Work: This role offers flexibility with remote work opportunities, fostering collaboration across geographical locations.
    • Global Exposure: Work on international projects and gain exposure to global regulatory environments and industry standards.

    If you are a skilled Medical Writer with a passion for clear, concise scientific communication, apply today to join Parexel and contribute to advancing medical research and improving patient outcomes worldwide.

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