Senior Medical Writer

Job Description

AccountabilitySupporting ActivitiesAggregate reports

• Preparing/Updating/Merging RMPs/Company Core-RMPs (CC-RMPs), preparing health authority response document along with RMS update in accordance with client requirements/conventions and SOPs
• Managing scheduled and unscheduled aggregate reports including but not limited 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), comparison document 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 conventions and SOPs
• Conducting critical appraisal and systematic review of literature with a focus on background epidemiology, specifically information on the incidence, prevalence and risk factor in patient populations, for inclusion in drug Safety Reports and RMPs
• Providing input and developing literature search strategies for the epidemiology section of safety reports
• Applying epidemiological methods and calculations to data available in literature to support the background rates of the issues under evaluation for the safety reports
• Performing aggregate report compliance activities including quality review to check the data/facts and internal consistency across various type of aggregate reports including but not limited to PBRERs, Ad hocs, HHEs, LJDs, tables, RMP, Pharmacovigilance System Master File (PSMF) document (as applicable)
• Generating Line Listings for submissions/ to identifying discrepancies and ensuring resolution of the discrepancies
• Distribution of final reports to the stakeholders including partners, affiliates and submission to health authorities, according to the agreed timelines, distribution lists and email templates (as required)
• Scheduling and coordinating meetings/ Drafting meeting agenda and minutes/Tracking action items and soliciting follow-up for open issues

Clinical Study Report Narratives

• Coordinates and liaises with the members of Study Management Team (SMT)/Study In-charge or equivalent, to discuss the narrative template development process, narrative categories and review of the narratives (as required)
• Serves as primary client contact for narrative writing for an assigned study, agreeing/negotiating deliverable timelines, and addressing/resolving any narratives related issues (as required)
• Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs provided by the client and ensures their appropriate medical cohesiveness and assessment in accordance with the client s and Parexel s conventions/guidelines and Standard Operating Procedures
• Performs quality checks on the drafted narratives as required
• Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting.
• Provides CSR narrative review support to the SMT where requested
• Build and maintain collaborative relationships with SMTs for an efficient, productive, and professional working relationship (as applicable)

QualificationsSkills:

• 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 negotiate on behalf of the department to ensure resources, timelines and expectations are aligned
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• 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)
• Gains trust and establish a connection with the client beyond ones project, to gain repeat business and/or to widen existing scope and services.
• Provides departmental expertise and perspectives to promote prospective business opportunities.
• 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

.Knowledge and Experience:

• Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
• Good knowledge of medical terminologies

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

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Keyskills :
protocolsmentoringsafetymedical writingclinical researchms office suitems officedrug safetyfinal qualityclient contactquality controlrisk managementproblem solvingrisk evaluationsafety statements