Sr. Medical Writer Job at Gandiv Insights LLC in Round Lake
Gandiv Insights LLC, Round Lake, IL, United States
2 days ago Be among the first 25 applicants
Are you an experienced
Medical Writer
passionate about delivering high-quality clinical and regulatory documentation? Join our growing team and play a key role in driving excellence in medical and scientific communications that support global drug development programs.
Responsibilities
Draft and edit documents supporting
clinical studies
— including
protocols, amendments, informed consent forms, and clinical study reports (CSRs) .
Develop and review
aggregate safety and efficacy reports
(IBs, PBRERs, DSURs, etc.).
Prepare and manage
regulatory submissions , including
briefing books
and
eCTD Module 2/5 clinical summaries .
Manage timelines, meetings, and document reviews across
cross-functional study teams .
Represent
Global Medical Writing
at cross-functional meetings and collaborate closely with clinical, regulatory, and biostatistics teams.
Provide
peer review, editing, and process improvement
support to ensure consistency and quality across documentation.
Qualifications
Bachelor’s degree or higher
(scientific background preferred).
6+ years
of medical writing experience in the
pharmaceutical/biotech industry
(or 10+ years in medical/scientific writing roles).
Strong understanding of
drug development ,
clinical study design , and
regulatory documentation .
Experience writing
protocols, CSRs, INDs, BLAs/NDAs, PBRERs, and DSURs .
Familiarity with
AMA, CBE, and Chicago style guides
and
medical dictionaries
(MedDRA, WHO Drug).
Skilled in
Microsoft Office ,
document management systems
(Veeva, SharePoint, LiveLink), and
data interpretation
(tables, figures, and clinical data presentations).
Excellent
project management, communication, and leadership
skills.
This is an exciting opportunity to shape medical writing excellence, streamline global documentation, and collaborate across multidisciplinary teams in a fast-paced, mission-driven environment.
Apply now or DM me for more details! anupam@gandivainsights.com
#Hiring #MedicalWriter #SrMedicalWriter #RemoteJobs #PharmaJobs #ClinicalResearch #RegulatoryWriting #ClinicalDevelopment #LifeSciences #PharmaceuticalJobs #MedicalWriting #BiotechJobs #DrugDevelopment #HealthcareJobs #NowHiring #WritingCareers #QAJobs #ClinicalTrials #MedicalCommunications #ScientificWriting #GlobalMedicalWriting
#J-18808-Ljbffr
Are you an experienced
Medical Writer
passionate about delivering high-quality clinical and regulatory documentation? Join our growing team and play a key role in driving excellence in medical and scientific communications that support global drug development programs.
Responsibilities
Draft and edit documents supporting
clinical studies
— including
protocols, amendments, informed consent forms, and clinical study reports (CSRs) .
Develop and review
aggregate safety and efficacy reports
(IBs, PBRERs, DSURs, etc.).
Prepare and manage
regulatory submissions , including
briefing books
and
eCTD Module 2/5 clinical summaries .
Manage timelines, meetings, and document reviews across
cross-functional study teams .
Represent
Global Medical Writing
at cross-functional meetings and collaborate closely with clinical, regulatory, and biostatistics teams.
Provide
peer review, editing, and process improvement
support to ensure consistency and quality across documentation.
Qualifications
Bachelor’s degree or higher
(scientific background preferred).
6+ years
of medical writing experience in the
pharmaceutical/biotech industry
(or 10+ years in medical/scientific writing roles).
Strong understanding of
drug development ,
clinical study design , and
regulatory documentation .
Experience writing
protocols, CSRs, INDs, BLAs/NDAs, PBRERs, and DSURs .
Familiarity with
AMA, CBE, and Chicago style guides
and
medical dictionaries
(MedDRA, WHO Drug).
Skilled in
Microsoft Office ,
document management systems
(Veeva, SharePoint, LiveLink), and
data interpretation
(tables, figures, and clinical data presentations).
Excellent
project management, communication, and leadership
skills.
This is an exciting opportunity to shape medical writing excellence, streamline global documentation, and collaborate across multidisciplinary teams in a fast-paced, mission-driven environment.
Apply now or DM me for more details! anupam@gandivainsights.com
#Hiring #MedicalWriter #SrMedicalWriter #RemoteJobs #PharmaJobs #ClinicalResearch #RegulatoryWriting #ClinicalDevelopment #LifeSciences #PharmaceuticalJobs #MedicalWriting #BiotechJobs #DrugDevelopment #HealthcareJobs #NowHiring #WritingCareers #QAJobs #ClinicalTrials #MedicalCommunications #ScientificWriting #GlobalMedicalWriting
#J-18808-Ljbffr