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    Senior Medical Writer

    Parexel
    0-2 years
    Not Disclosed
    Remote
    10 Jan. 13, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Medical Writer Role at Parexel

    As a Medical Writer at Parexel, you will leverage your robust scientific knowledge, exceptional writing abilities, and patient-focused approach to convey complex scientific information effectively. Your audience will include regulatory agencies, medical professionals, and the general public. This role requires collaboration within cross-functional teams to develop diverse clinical research documents such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.

    We foster a culture of inclusivity, collaboration, and support, empowering employees to make a meaningful impact on people's lives. Our commitment to your growth includes continuous learning opportunities such as mentoring, job shadowing, job rotation, stretch assignments, and leadership roles. Your career development and promotions will align with global standards and your personal development plan.

    Success Profile

    Do you possess the following soft skills and traits to thrive at Parexel?

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

    About This Role

    As a Medical Writer, you will be responsible for:

    Document Management

    • Handling scheduled and unscheduled aggregate reports, including:
      • Periodic Safety Reports (PSRs), such as PSURs, PBRERs, ACOs, SASRs, and Corporate Addendum Reports.
      • U.S. Periodic Adverse Drug Experience Reports (PADERs).
      • Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) reports, Risk Management Plans (RMPs), and more.
    • Comparing local and global labeling documents and ensuring International Non-proprietary Names (INNs) are included in PSRs per client requirements.

    Signal Detection and Management

    • Conducting qualitative and quantitative signal detection reviews and analyses from sources such as regulatory authority databases, client databases, literature, and regulatory websites.
    • Managing the end-to-end signal process, including signal tracking, assessment, review meetings, and presentations in collaboration with the Global Safety Officer (GSO).
    • Supporting signal detection and evaluation activities per standard operating procedures (SOPs) and guidelines.

    Safety Profile Knowledge

    • Maintaining an in-depth understanding of the adverse event safety profiles of assigned drugs, relevant labeling documents, client guidelines, SOPs, and international drug safety regulations.

    Regulatory Compliance

    • Staying aware of global regulatory reporting obligations and organizing workloads to meet internal and regulatory timelines for adverse event reporting.

    Quality and Training

    • Ensuring all work meets high-quality standards and adhering to performance metrics defined by clients.
    • Preparing for, participating in, and following up on audits and inspections.
    • Delivering project-specific training to new team members and imparting guidance as needed.

    Client Interaction and Collaboration

    • Acting as the primary client contact, collaborating with relevant client functions to deliver high-quality work.
    • Addressing and incorporating reviewer feedback into draft reports while liaising with contributors to resolve comments.

    Leadership and Mentorship

    • Delegating tasks to Associate Medical Writers and Medical Writers I as appropriate.
    • Striving to enhance client satisfaction based on feedback.
    • Providing mentorship and support to team members to foster their growth.

    This role offers the opportunity to make a significant impact while growing professionally in a dynamic, supportive, and globally connected environment.

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