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Medical Writer Ii

2+ years
Not Disclosed
10 Dec. 23, 2024
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

Job Title: Medical Writer (Pharmacovigilance)

Location: Remote
Department: Parexel Medical Writing


About Parexel:

At Parexel, we are committed to advancing global health by helping biopharmaceutical companies navigate regulatory landscapes and bring innovative therapies to patients faster. As a Medical Writer, you will play an essential role in effectively communicating complex scientific data to stakeholders, including regulatory agencies, healthcare professionals, and the general public. By leveraging your scientific knowledge and writing skills, you will contribute to the development of key clinical research documents that are critical to the safety and efficacy evaluation of medical treatments.

We provide a collaborative, inclusive work environment that supports continuous learning and professional development. You’ll have opportunities for mentorship, job rotation, and stretch assignments, all designed to help you expand your expertise and advance your career.


Success Profile:

To succeed at Parexel, you should have the following soft skills and interpersonal traits:

  • Adaptable: Ability to thrive in a dynamic, fast-paced environment.

  • Communicator: Clear, concise, and effective communication skills.

  • Consistent: Ability to maintain high standards of quality and efficiency in all tasks.

  • Deadline-oriented: Strong time management skills to meet deadlines.

  • Detail-oriented: Focused on accuracy and precision.

  • Insightful: Able to analyze data and make informed decisions.


Job Purpose:

As a Medical Writer, you will be responsible for preparing and managing a variety of aggregate reports related to pharmacovigilance and safety monitoring, such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and Clinical Study Reports (CSRs). You will also work with cross-functional teams to ensure high-quality regulatory submissions and reports that comply with global regulatory standards.


Key Accountabilities:

Aggregate Reports:

  • Manage and prepare scheduled and unscheduled pharmacovigilance reports including PSURs, PBRERs, DSURs, PADERs, and other safety-related documents.

  • Conduct critical appraisals and literature reviews to support the epidemiology sections of safety reports.

  • Generate Line Listings and drug lists, ensuring data consistency and accuracy.

  • Review and revise document drafts, ensuring inclusion of all relevant input before distribution.

  • Coordinate meetings, track action items, and follow up on open issues to ensure timely completion of reports.

Clinical Study Report Narratives:

  • Collaborate with Study Management Teams (SMT) to develop and review narrative templates and categories.

  • Prepare clear and accurate narratives based on clinical database outputs and safety data.

  • Perform quality checks on narrative drafts to ensure medical cohesiveness and adherence to Parexel and client conventions.

  • Provide narrative review support to the SMT as needed.

Signal Detection and Management:

  • Perform qualitative and quantitative signal detection and analysis from various sources, including regulatory databases and literature.

  • Manage the end-to-end signal detection process, including signal tracking, assessment, and presenting findings.

  • Support signal evaluation activities in accordance with SOPs and guidelines.

General Responsibilities:

  • Maintain awareness of global regulatory reporting obligations and ensure compliance with timelines for adverse event reporting.

  • Serve as the primary client contact for narrative writing and safety report preparation.

  • Mentor and guide new recruits, ensuring high-quality training and development.

  • Participate in audits, inspections, and internal training sessions.

  • Contribute to process improvement initiatives to enhance project efficiency and quality.


Skills and Experience:

  • Strong analytical and problem-solving skills.

  • Excellent verbal and written communication skills with the ability to write unambiguous medical text.

  • Organizational skills to manage multiple tasks and deadlines.

  • Experience in regulatory affairs, pharmacovigilance, or related fields is desirable.

  • Fluency in written and spoken English is essential.

  • Proficiency with web-based applications and MS Office suite (Word, Excel, PowerPoint).

  • Experience in signal detection, narrative writing, and regulatory submissions.

  • Ability to work collaboratively and independently in a matrix environment.


Education and Qualifications:

  • Required: A university degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).

  • A degree in Medicine, Dentistry, Physiotherapy, or Nursing is an advantage.


Why Parexel?

At Parexel, we offer a supportive and inclusive environment that fosters growth and professional development. We encourage our employees to take on new challenges, build their skills, and make meaningful contributions to healthcare. With remote work flexibility and a focus on career progression, Parexel is the ideal place for passionate, driven professionals who want to make an impact.


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