Senior Medical Writer
1 - 5 Years
Bengaluru/Bangalore
Job Description
Essential Function
The Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other PAREXEL departments and clients to set and meet internal and external deliverable timelines, leadership, training and support of junior medical writing staff.
Relationships
Reports To Departmental Line Management, Medical Writing Services
Directly Supervises None
Provides Work Direction to Medical Writers, Associate Medical Writers, Medical Writing Assistants
Works Closely with Project Managers/ Leaders, Physicians, Biostatisticians, Data Managers, Regulatory Associates, Medical Writing staff
External Relationships Client technical representatives
Key Accountabilities
Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/ aggregate reports, integrated summaries of safety and efficacy.
Act in the capacity of project manager/ lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
Ensure document content and style adheres to FDA/ EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.Company Profile
The Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other PAREXEL departments and clients to set and meet internal and external deliverable timelines, leadership, training and support of junior medical writing staff.
Relationships
Reports To Departmental Line Management, Medical Writing Services
Directly Supervises None
Provides Work Direction to Medical Writers, Associate Medical Writers, Medical Writing Assistants
Works Closely with Project Managers/ Leaders, Physicians, Biostatisticians, Data Managers, Regulatory Associates, Medical Writing staff
External Relationships Client technical representatives
Key Accountabilities
Write clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/ aggregate reports, integrated summaries of safety and efficacy.
Act in the capacity of project manager/ lead for medical writing projects. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
Serve as the Medical Writing representative on assigned project teams, providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables. Identify any potential project challenges to departmental line management and project leader including changes in project plan, timeline or out of scope requests, and suggest possible resolution options.
Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
Ensure document content and style adheres to FDA/ EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.Company Profile
PAREXEL International Corporation is a leading global bio/ pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in approximately 70 locations throughout over 50 countries around the world, and has more than 13,000 employees. At PAREXEL, we have a passion for making a profound difference. As an expertise-based business, the caliber of our people and their dedication directly impacts our success, the success of our clients, and the ability to make a difference in the lives of patients worldwide. You'll be surrounded by supportive leadership and a brilliant team who share a common goal - to improve the lives of millions of patients.
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