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Job Summary:
The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.
Key Accountabilities:
Note: The below statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities required for the position. Responsibilities vary as applicable.
Aggregate 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 RiskBenefit 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)
Signal Detection and Management:
- Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.
- Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO
- Conduct/support signal detection and evaluation activities according to SOPs and guidelines
General:
- Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations
- Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting
- Maintaining a good working knowledge of the assigned Clinical studies for narratives
- Attending/conducting internal, drug safety and project specific training sessions
- Imparting trainings to the new starts during the induction sessions and the team as required.
- Demonstrating document leadership: communicating content requirements, coordinating and conducting interdepartmental team review of draft and final documents, scheduling and leading/facilitating authoring team meetings to agree on expectations, evaluating progress on tasks, identifying issues and facilitating resolutions, managing/driving the timeline.
- Preparation for, participation in, and follow up on audits and inspections
- Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
- Striving to enhance client’s satisfaction based on feedback provided by the client
- Helping in management of process related queries at user level.
- Acting in the capacity of lead, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving projectrelated issues. Project management of contractual and financial aspects, as necessary with guidance from management.
- Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
- Evaluating and incorporating reviewer comments in draft reports and liaising with relevant contributors for resolution of comments
- Identifying areas of concern within the team and raising the issues with project manager
- Mentoring new recruits in the team, if required
- Archiving the source documents and relevant emails as required
- Responding to clients/customers in a timely manner
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 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 one's 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:
- 5+ years of direct experience in Regulatory Writing in a CRO or Pharma company setting
- 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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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
