Parexel is offering exciting work from home medical writer opportunities across India. As a medical writer, you will utilize your scientific knowledge and writing skills to communicate complex data to various stakeholders, including regulatory agencies, medical professionals, and the general public. If you hold a degree in life sciences or medicine and are looking for a remote position, this could be the perfect opportunity for you.
Role Overview
Job Title: Medical Writer I Location: Remote, India
Job Purpose:
- Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including 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) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).
- Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
- Responsible for preparing the narratives associated with the client’s/sponsor’s products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and client’s/sponsor’s requirements
- Scheduling and Attending meetings/ Drafting meeting agenda and minutes/Tracking action items.
Key Responsibilities
- Aggregate Reports Management: Prepare and manage various scheduled and unscheduled aggregate reports, including PSURs, PBRERs, and DSURs.
- Clinical Study Report Narratives: Develop clear and accurate narratives based on clinical and safety database outputs.
- Signal Detection and Management: Conduct signal detection reviews and manage the end-to-end signal management process.
- General Responsibilities: Maintain knowledge of adverse event safety profiles, global regulatory reporting obligations, and participate in training sessions, audits, and inspections.
Skills
- Analytical and problem-solving skills
- Excellent interpersonal skills
- Excellent verbal / written communication skills
- Excellent organizational and prioritization skills
- Ability to work collaboratively and effectively in a team environment
- Client focused approach to work
- Ability to evaluate data and draw conclusions independently
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Ability to understand all necessary steps in a project, plan steps ahead, and identify critical paths.
- Fluency in written and spoken English
- Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
- Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
- Typing and transcription accuracy
- Awareness of global culture and willingness to work in a matrix environment.
Work from home Medical Writer Opportunities at Parexel | Remote Jobs[/caption]
Qualifications
- Education:
- Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage
- Experience: Previous experience in regulatory, pharmacovigilance, or a related field is desirable.
