Job Details

- Designation : Medical Writer

- Department : Consumer Research

- Qualification : M.Sc, B.Pharma, M. Pharma

- Experience : Min: 1 Year(s) - Max: 5 Year(s)

- Location : Sigma

Primary Skills

- Medical Writing

- Positive Clinical Practice

- Clinical Protocol

- Clinical Study Report

- Clinical Study Design

Responsibilities

1. Principally responsible to design Clinical study Protocols, Standard Operating Procedures (SOPs), Clinical Study Reports, Case Report forms, Informed Consent documents/assent forms, etc., working policies, Pre-study meeting presentations, Training Manuals, Study Synopsis, protocol appendices, and any other documents according to project needs and per regulatory requirements.

2. Responsible to design Personal Healthcare Training Manuals per instructions of Head of the Department.

3. Conducting project tracking meeting of PHC with other stakeholders.

4. Hard binding of final CSR and submitting to sponsor.

5. Final package of CD/DVD of raw data submission to sponsor.

6. Responsible for EC coordination, submission and approval in consultation with Head of Department/Site Manager.

7. Archiving of completed projects.

8. Develop and review SOPs pertaining to operations of the unit, clinical conduct of the studies and bio-instruments.

9. Assist to perform trial related activities such as application, removal, dosing supervision, instrument operation, subjective perception from subjects, etc.), or any other assigned activities, collaborated inter departmental/Sponsor communications and other trial related activities such as training to study team.

10.



Assist Investigator and Head of Department/Site Manager for planning and execution of personal healthcare clinical trials in compliance with all standard operating procedures, other systems of Karmic Lifesciences LLP and applicable regulations.

11. Aid PHC team to ensure strict adherence to protocol, patient/subject compliance, ICH-GCP procedures, SOPs and applicable regulatory guidelines.

12. Performs or supervises the conduct of study-related procedures.

13. Manage and motivate the investigational staff and other disciplines involved and take measures to minimize any potential risks.

14. Responsible for study closeout & follow up activities in order to maintain documents at the site.

15. Ensure to follow and adherence of organization's general rules and applicable policies.

16. Any additional responsibilities given by Head of the Department / Management.

Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of task to which the employee may be assigned.

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Role: Medical Writer,

Industry Type: Clinical Research / Contract Research,

Department: Research & Development,

Employment Type: Full Time, Permanent

Role Category: Pharmaceutical & Biotechnology

Education

UG: Any Graduate

PG: Any Postgraduate

Key Skills clinical study reportclinical trialscomplianceconsumer researchcsrecgcphealthcaremedical writermedical writingoperationspharmaproject trackingresearchsigma

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