Job Summary
Locations:
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Stream:
• Pharmacy
Function:
Role:
• Medical Affairs Manager
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Summary:
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Greetings,
The company is among leading pharmaceutical injectable manufacturers in the world with ISO & WHO, EU-GMP Certifications. Research centre is fully equipped interdisciplinary drug discovery and development centre, duly accredited with GLP and approved by the DSIR. The company provides formulations in area of anti–biotics and oncological therapeutics. Company has manufacturing facilities located in India and abroad. Company manufactures Oncological and Cefelosporine Injectable products.
Position- Scientific Affairs
Job location:- Panchkula / Baddi
Job Description:-
Taking care of Regulatory domain, scientific communications, Research & development, Training & development, Project management.
Understanding of CTD Modules 2, 4 and 5 for generic/innovator product filings
Understanding of documents like Company core safety data sheets (CCDS) and summary of product characteristics (SPCs), risk management plans (RMPs), and public summaries for EMEA (generic and innovator) filings
Understanding of IBs, safety narratives, CSPs and CSRs
Responses of queries from various regulatory authorities
Manuscripts (Preclinical and clinical research)
Technical briefs and product monographs
CMEs related scientific communication
In vitro PK/PD modeling studies (infectious diseases)
Population pharmacokinetics
Development and implementation of quantitative mechanism based PK/PD models
Training of team members (Scientific Affairs & Product Management) on different projects (covering both technical and non-technical expectations)
KRA and competency matrix assessment of team
Technical training to product management teams
Budgeting , resource optimization, work allocation
Identification of risk areas in process and their control
Handling multiple projects and ensuring timed completion of the task.
Required candidate:-
Experience:- 3- 10 years
Experience in clinical and preclinical research
Taking care of Regulatory domain, scientific communications, Research & development, Training & development, Project management,
Understanding of CTD Modules 2, 4 and 5 for generic/innovator product filings, Company core safety data sheets (CCDS) and summary of product characteristics (SPCs), risk management plans (RMPs), and public summaries for EMEA (generic and innovator) filings, IBs, safety narratives, CSPs and CSRs, Manuscripts , CMEs , In vitro PK/PD modeling studies (infectious diseases), Population pharmacokinetics
Experience in Budgeting , resource optimization, work allocation
Experience in Handling multiple projects
Qualification- PHD Pharmacology, medicine
Salary Structure-Depends upon current salary, experience etc.
If you find the job profile as per your needs then apply to us by sending following at [HIDDEN TEXT]
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ABOUT US :-
Sneh Consultancy is reckoned as one of the top Recruitment / Selection and Executive search firm in India having country wide presence. With its ethical foundation, value system and result oriented service delivery; Sneh Consultancy today is an extended HR arm to its clients and a trusted Consultancy organization to the Job Seekers
Looking forward to hear from you, in order to give your career a new height.
Thanks & warm regards
Sneh Consultancy services
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Scientific Affairs Department for leading Pharmaceutical manufacturer
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