PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Senior Medical Writer
Information Content Authoring
• Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities.
• Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
• Draft and/or ghost-write clinical documents for more experienced medical writers
• Act as support to others in the team to ensure that all documentation is accurate and encompasses all relevant information based on Stakeholder needs.
• Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, central content, and general guidelines for clinical documentation and workflow procedures.
• Initiate and participate in marketing initiatives, such as white paper, abstract, poster, and manuscript development
Document Project Management
• Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues.
• Serve as the medical writing representative on assigned project teams communicate content requirements, lead/facilitate authoring team meetings to agree on expectations
• Coordinate and conduct interdepartmental team reviews of draft and final documents,
• Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Calyx and/or client guidelines/SOPs.
• Distribute final documents to project team and client in a timely manner and to agreed timescales
• Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options.
• Attend project team meetings as required.
• Ensure appropriate filing of applicable project documentation
• May provide project management of contractual and financial aspects.
• Implements stakeholder engagement/communications plan.
• Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information.
• Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management.
• Helps develop and enhance customer and stakeholder relationships
• Uses appropriate methods and a systematic approach in the development, maintenance, control and distribution of documents.
• Prepares documents for publishing readiness, ensuring document consistency and integrity
• Ensures documentation adheres to FDA/EMA or other appropriate regulatory guidelines, and / or relevant SOPs.
• Provides medical editing review of draft and final documents prepared by other medical writers before internal or external distribution. This includes both copyediting and content review.
Follows required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.
• Makes changes to and controls the updates and distribution of quality standards.
Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience
Qualification : B.Pharm, B.Sc
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th October, 2021
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