Senior Medical Writing Specialist REMOTE

3 days ago

Mon Village, India DivIHN Integration Inc Full time
For further inquiriesregarding the following opportunity please contact one of ourTalent Specialists
Divya at
Sivanesan at Title: Senior Medical Writing Specialist(REMOTE)
Location: Remote
Duration: 6Months Description:

The healthcare industry requires that we abide by regulations fromall around the world. Part of the requirements is to produceclinical documents which support the safety and efficacy of ourproducts. The Senior Medical Writing Specialist in WorldwideMedical Advanced Surgery will write and edit clinical documents tosupport regulatory submissions for relevant products. The idealcandidates must have a scientific background and be fluent inEnglish (both writing and speaking).
Essential Duties andResponsibilities:
With oversight develops highquality clinical documents ensuring scientific excellence andregulatory compliance. The development process includes writinginterpreting and summarizing clinical and nonclinical datacompiling information and ensuring delivery withintimelines.
Clinical documents may include investigatorbrochures protocols clinical study reports integrated reportsclinical sections of core technical documents/new drugapplications/briefing documents per regulationsmanuscripts/abstracts for publication and/orpresentation.
Ensure compliance of clinical documentswith national and international regulatory requirements andguidelines and Client procedures (as applicable).
Workclosely with cross functional team members and serve as MWrepresentative at study team meetings.
Prepare documenttimelines with guidance from manager as needed.
Conductliterature searches.
Develop deeper knowledge ofspecific therapeutic areas.
Qualifications:
Experience inscientific and/or medical writing.
Experience in theanalytical evaluation of scientific data and written or oralpresentation in a logical clear concise manner.
Strongorganizational skills and meticulous attention todetail.
Familiarity with clinical trialrelated andregulatory clinical submission templates and documents
Ability to apply global regulatory authority regulations and/orguidance.
Manage multiple projects with competingpriorities.
Experience working in a team environment(remotely) as well as independently.
Medical statisticsknowledge
Proficient in Mircosoft Office Suite (WordExcel PowerPoint OneNote Outlook Teams
Education and/orExperience:
The Senior Medical WritingSpecialist must have a BS or MS in scientific or clinicaldiscipline with excellent writing skills. 5 years of onthejobexperience in scientific/medical writing (e.g. clinical trial andregulatory documents) preferred but not mandatory.

About us: DivIHN the IT Asset PerformanceServices organization provides Professional Consulting CustomProjects and Professional Resource Augmentation services to clientsin the MidWest and beyond. The strategic characteristics of theorganization are Standardization Specialization andCollaboration. DivIHN is an equal opportunity employer.DivIHN does not and shall not discriminate against any employee orqualified applicant on the basis of race color religion (creed)gender gender expression age national origin (ancestry) disabilitymarital status sexual orientation or military status.

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