Pharma Job : Medical Writer Posts Vacant for BSc & MSc Candidates @ Apotex

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15692942 - beautiful young medical intern in hospital

Apotex Inc

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 10,000 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies has over 6,000 employees. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe.

Job Title:    Medical Writer

No. of Posts:   2

Salary:  INR 3,00,000 – 7,00,000 P.A.

Job Description:

Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) best practices and regulatory requirements.

Job Responsibilities:

1. Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Centers Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
2. Preparation of integrated clinical study report for

the bioequivalence studies.
3. Collection, reviewing and summarizing (such as data entry onto the data base / clinical report templates) of clinical data and preparation of the clinical report as per e-CTD requirement.
4. CRF scanning, OCR and book markings as per e-CTD requirement.
5. Preparation of FDA DBE, CSBE tables and as per other regulatory requirements as applicable.
6. Performs and ensures clinic staff activities for compliance with protocol and SOPs.
7. Performs dosing related activities (such as dosing, dosing supervision, Test Article verification and mouth check).
8. Preparation and/or review of report tables for the allotted studies.
9. Performs the review of the study data for completion, correctness and accuracy.
10. Executes other duties as per the study specific protocol requirements and as may be assigned by the Clinical Operations Management/delegate as training and experience allow.
11. Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
12. Assists in the creation, development and revision of the Bioequivalence Centers Clinical Operations Department Standard Operating Procedures.

Qualifications: 

1. B. Pharmacy / M. Pharmacy / Pharma-D / MSc.

2. 2-3 years of experience Preferable

Education

  • UG:B.Pharma – Pharmacy
  • PG:M.Pharma – Pharmacy

Apply Online

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