Medical Writer I

1-3 years years

Preffered by Company

Remote

10 July 15, 2024

Job Description

Job Type: Full Time Education: B.Pharm/M.Pharm/PharmD 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 Opening: Medical Writer I

Location: India (Remote)

Company: Parexel

Overview

About this Role:
As a Medical Writer at Parexel, you will leverage your strong scientific knowledge, writing skills, and patient focus to effectively communicate complex scientific data to various stakeholders, including regulatory agencies, medical professionals, and the general public. You will collaborate within cross-functional teams to develop a wide range of clinical research documents, such as model informed consent forms, clinical study reports, pharmacovigilance documents, and more.

Our Culture:
We foster a culture of inclusivity, collaboration, and support that empowers our employees to make a meaningful impact on people's lives. We offer continuous learning opportunities, from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team. Your development and promotion are based on global standards and your personal development plan.

Success Profile

Essential Soft Skills and Traits:

Adaptable
Communicator
Consistent
Deadline-oriented
Detail-oriented
Insightful

About This Role

Job Purpose:
You will be responsible for managing scheduled and unscheduled aggregate reports, including but not limited to Periodic Safety Reports (PSRs), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) reports, Risk Management Plans (RMPs), Safety statements, Health Hazard Evaluations (HHEs), Drug Safety Reports (DSRs), Clinical Overviews (COs), Safety Evaluation Reports (SERs), and Investigational New Drug Annual Reports (INDARs). You will also prepare documents comparing local and global labeling documents and checking International Non-proprietary names (INNs) for inclusion in PSRs as per client requirements.

Key Accountabilities:

Aggregate Reports:
- Prepare/update/merge RMPs/Company Core-RMPs (CC-RMPs)
- Manage scheduled and unscheduled aggregate reports
- Conduct critical appraisal and systematic review of literature for inclusion in safety reports and RMPs
- Generate Line Listings for submissions and identify discrepancies
- Ensure high quality and consistency across documents
Clinical Study Report Narratives:
- Prepare clear and accurate narratives based on Clinical and Safety Database outputs
- Perform quality checks on narratives and assist in compiling narrative deliverables
Signal Detection and Management:
- Perform signal detection review and analysis from various sources
- Manage the end-to-end signal management process
General:
- Maintain knowledge of adverse event safety profiles, labeling documents, client guidelines, and global safety regulations
- Organize workload to ensure compliance with timelines for adverse event reporting
- Mentor new recruits and attend training sessions
- Prepare for audits and inspections

Skills

Analytical and problem-solving skills
Excellent interpersonal and communication skills
Organizational and prioritization skills
Ability to work collaboratively in a team environment
Client-focused approach
Ability to evaluate data and draw conclusions independently
Flexibility with work assignments and new learning
Proficiency with computer applications, especially MS Office
Ability to write clear, accurate medical text

Knowledge and Experience

Experience in Regulatory/Pharmacovigilance or related field is desirable
Good knowledge of medical terminologies

Education

A university degree in life sciences/health or biomedical sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.)
A degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing is an advantage

Apply Now: Please visit Parexel Careers for more information and to submit your application.

Link: https://jobs.parexel.com/en/job/remote/medical-writer-i/877/67563645616

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Medical Writer I

Job Description

Job Opening: Medical Writer I

Overview

Success Profile

About This Role

Skills

Knowledge and Experience

Education

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