Opening in one of Leading CRO

Vacancy for medical writer

We have an excellent opening for the position of Medical Writer with one of the leading CRO .

Please find the Job Description below:

Job Title : Sr. Research Associate / Associate Scientist (Medical Writer)

Department: Bio pharmaceutics & Project Management

Reporting to: Project Manager

Location: Ahmedabad, India

Qualifications: M.Pharma

Experience: 5 to 7 yrs

Preferred industry: CRO \ Pharma

Special Skills:

* Good understanding of local (CDSCO) and international (USFDA, EMA, HPFB, ANVISA, TGA, MCC etc) regulatory guidelines for BA/BE studies.
* Good Communication Skills
* Excellent interpersonal, written and verbal communication skills. Fluent in English and local language (both verbal and written)
Proficient in Microsoft office (Word, Excel and PowerPoint) and Internet


Job Responsibilities

1.Preparation of Study documents:
* Preparation of Bio-availability and Bio-equivalence protocols as per applicable regulatory (USFDA, EMA, HPFB, ANVISA, TGA, MCC etc) requirements
* Prepare Informed Consent Documents (ICD) in English and coordinate for translation into Local language(s) and it's back translation
* Preparation of the CRFs and other working documents, if applicable
* Coordinate with different stake holders like Project Manager (PM), Investigator (PI/CI), Bio-analytical team, and Statistician for protocol, ICF and CRF preparation
* To incorporate the protocol comments received from Investigator, QC, QA, BR and Sponsor before finalization of the same
* To prepare protocol versions/amendments as and when required
* To prepare study documents required for regulatory submission like BE NOC, Test License

2. Preparation of Clinical and Non Clinical Expert Reports
* To do extensive literature survey on PK, PD, Efficacy & Safety study for preparing Clinical and Non Clinical Expert Reports
* To discuss the available literatures with Medical expert and select the appropriate literatures to referred for report preparation
* To prepare the Clinical and Non Clinical Expert Reports in consultation with the Medical expert

3.Feasibility of the study proposal
* Assist PM for feasibility assessment of study proposals
* Literature survey for PK & Safety study

4. IEC Communication:
* Coordinate with Principal Investigator (PI) and/or Clinical Investigator (CI) for application
* Prepare documents for submission to the Ethics Committee (EC)

5. Dose administration activity as required

6. Perform any other duties as assigned by line manager

If interested, kindly revert us back with your updated CV at
careers@primroseconsultancy.com

you can also contact us on
079-66172163

Company is most probably is VEEDA  clinical research