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Medical Writer
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#708339
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Job Description
T
TIGI HR Solution
Content Writer
TIGI HR Solution • गांधीनगर, Gujarat • Jooble के ज़रिए
4 दिन पहले
फ़ुल-टाइम
किसी डिग्री का ज़िक्र नहीं है
आवेदन करें: Jooble
आवेदन करें: Getmereferred.com
आवेदन करें: BeBee
आवेदन करें: Talent.com
Jobs.weekday.works पर सीधे आवेदन भेजें
आवेदन करें: Trabajo.org
आवेदन करें: Www.xopple.com
आवेदन करें: Jobrapido.com
काम का वर्णन
Creative Writer
Experience : 2 - 3 Years
Location : Gandhinagar
• 2-3 years of experience in creative copywriting, brand communication or content strategy.
• Portfolio showcasing range: Campaign lines, long-form storytelling, blogs, thought pieces, brand narratives and even microcopy.
• Strong command of narrative structure, rhythm and emotional tone.
• Ability to write in multiple brand voices ...
इस लिस्टिंग की शिकायत करें
V
Veeda Lifesciences
Medical Writer
Veeda Lifesciences • अहमदाबाद, Gujarat • Jooble के ज़रिए
4 दिन पहले
फ़ुल-टाइम
आवेदन करें: Jooble
आवेदन करें: LinkedIn
आवेदन करें: Getmereferred.com
Jobaaj पर सीधे आवेदन भेजें
आवेदन करें: Adzuna
आवेदन करें: JobLeads
आवेदन करें: Recruit.net
Jobs.weekday.works पर सीधे आवेदन भेजें
काम का वर्णन
Veeda Lifesciences is seeking a Medical Writer With a relevant experience in Clinical Trials.
This is a full-time job, With a flexibility of Hybrid Working.
Job Requirements:
B-Pharm, M-Pharm, Pharm- D or relevant field
At least of 2 Years working experience in the field
Excellent command of spoken and written English
Ability to work independently but also as part of the team with minimal supervision
Ability to work with multiple priorities and tight deadlines
Main role and responsibilities:
• Ct documents like protocol / CSR for patient based CT involving molecules for regulated market
• Preparation & Review of Protocol, ICD, Synopsis and other study specific documents e.g. patient diary card.
• Preparation & Review of Investigator Brochure.
• Evaluating trial feasibility (preliminary and detailed) for patient based clinical studies along with medical team for various regulatory submissions.
• To support in reference literature search as required for assigned projects.
• Providing the Protocol Training to Monitors and site team if required.
• Preparation & Review of Clinical study report (CSRs) for phase trials conducted by Clinical Operations Department of Veeda as per regulatory requirement and define timeline in project grid - Study execution sheet in coordination with the Project Manager.
• Preparation & Review of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.
• Preparation and finalization of clinical study report and related appendices/documents for adequacy to be submitted as part of CTD/eCTD as per applicable regulatory requirements.
• Review of statistical analysis plans, mock shells and table/figure/listing specifications for appropriate content.
• Perform literature searches/reviews as necessary to obtain background information and development of documents.
• Compliance to sponsor audit and regulatory inspections (e.g., USFDA, EMA, DCGI etc.) and query/deficiencies reply.
• To ensure and improve quality & presentation of report through writing, editing and/or managing the production of high-quality clinical documentation (e.g., Study Report, Summary Documents and ensure compliance of documentation to internal company standards and external regulatory guidelines).
• Preparation and review of departmental SOP and other departmental SOPs as required.
• Ensure that the reports and appendices and related material are archived / e-archived in a timely manner.
• Preparation of project summary and submit to reporting head/designee
• Develop and maintain the necessary templates, formats and styles to ensure that documents generated meet the industry, internal, client & regulatory requirements.
• Participate in departmental or interdepartmental process improvement and training initiatives.
TIGI HR Solution
Content Writer
TIGI HR Solution • गांधीनगर, Gujarat • Jooble के ज़रिए
4 दिन पहले
फ़ुल-टाइम
किसी डिग्री का ज़िक्र नहीं है
आवेदन करें: Jooble
आवेदन करें: Getmereferred.com
आवेदन करें: BeBee
आवेदन करें: Talent.com
Jobs.weekday.works पर सीधे आवेदन भेजें
आवेदन करें: Trabajo.org
आवेदन करें: Www.xopple.com
आवेदन करें: Jobrapido.com
काम का वर्णन
Creative Writer
Experience : 2 - 3 Years
Location : Gandhinagar
• 2-3 years of experience in creative copywriting, brand communication or content strategy.
• Portfolio showcasing range: Campaign lines, long-form storytelling, blogs, thought pieces, brand narratives and even microcopy.
• Strong command of narrative structure, rhythm and emotional tone.
• Ability to write in multiple brand voices ...
इस लिस्टिंग की शिकायत करें
V
Veeda Lifesciences
Medical Writer
Veeda Lifesciences • अहमदाबाद, Gujarat • Jooble के ज़रिए
4 दिन पहले
फ़ुल-टाइम
आवेदन करें: Jooble
आवेदन करें: LinkedIn
आवेदन करें: Getmereferred.com
Jobaaj पर सीधे आवेदन भेजें
आवेदन करें: Adzuna
आवेदन करें: JobLeads
आवेदन करें: Recruit.net
Jobs.weekday.works पर सीधे आवेदन भेजें
काम का वर्णन
Veeda Lifesciences is seeking a Medical Writer With a relevant experience in Clinical Trials.
This is a full-time job, With a flexibility of Hybrid Working.
Job Requirements:
B-Pharm, M-Pharm, Pharm- D or relevant field
At least of 2 Years working experience in the field
Excellent command of spoken and written English
Ability to work independently but also as part of the team with minimal supervision
Ability to work with multiple priorities and tight deadlines
Main role and responsibilities:
• Ct documents like protocol / CSR for patient based CT involving molecules for regulated market
• Preparation & Review of Protocol, ICD, Synopsis and other study specific documents e.g. patient diary card.
• Preparation & Review of Investigator Brochure.
• Evaluating trial feasibility (preliminary and detailed) for patient based clinical studies along with medical team for various regulatory submissions.
• To support in reference literature search as required for assigned projects.
• Providing the Protocol Training to Monitors and site team if required.
• Preparation & Review of Clinical study report (CSRs) for phase trials conducted by Clinical Operations Department of Veeda as per regulatory requirement and define timeline in project grid - Study execution sheet in coordination with the Project Manager.
• Preparation & Review of Full CSRs, Abbreviated CSR, Synoptic CSR, Shell and Interim report as per Sponsor necessity.
• Preparation and finalization of clinical study report and related appendices/documents for adequacy to be submitted as part of CTD/eCTD as per applicable regulatory requirements.
• Review of statistical analysis plans, mock shells and table/figure/listing specifications for appropriate content.
• Perform literature searches/reviews as necessary to obtain background information and development of documents.
• Compliance to sponsor audit and regulatory inspections (e.g., USFDA, EMA, DCGI etc.) and query/deficiencies reply.
• To ensure and improve quality & presentation of report through writing, editing and/or managing the production of high-quality clinical documentation (e.g., Study Report, Summary Documents and ensure compliance of documentation to internal company standards and external regulatory guidelines).
• Preparation and review of departmental SOP and other departmental SOPs as required.
• Ensure that the reports and appendices and related material are archived / e-archived in a timely manner.
• Preparation of project summary and submit to reporting head/designee
• Develop and maintain the necessary templates, formats and styles to ensure that documents generated meet the industry, internal, client & regulatory requirements.
• Participate in departmental or interdepartmental process improvement and training initiatives.
