Job as Scientific And Compliance Manager in Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Scientific And Compliance Manager

Job Description
The position provides a critical role in ensuring quality (scientific and editorial) deliverables of all projects being delivered by a Function. The role is responsible for scientific and compliance review of content developed by the Function ensuring high quality deliverables meeting customer expectations within timelines.
•To ensure and enable overall quality and compliance of scientific writing projects.
•To review, in collaboration with the writing team, all medical communication deliverables for clarity, consistency, grammar, syntax, writing style, data accuracy and meeting congress and journal requirements.
•To ensure that comments and feedback received from internal and external stakeholders and customer specifications for all documents delivered from a function are addressed appropriately and consistently.
•To provide coaching and training to medical writers and Group/Team Leaders on compliance and scientific quality.
•To track quality and drive consistency within and across Line Functions. Work closely with the FHs to identify training requirements and drive quality and compliance initiatives.
•To ensure deliverables are in compliance with Novartis internal writing specification tools and guidelines including
•To ensure that publications are consistent with GPP2- good publications practice; ICJME, Consort, and internal Novartis SOPS. •Working in collaboration with Function Heads responsible for updating any internal writing specification tools and guidelines. Exceptional written and oral communication, interpersonal, organizational, and problem-solving skills; attention to details.
• Exceptional ability to work collaboratively with teams, manage multiple projects, with changing priorities and specifications.
• Ability to work independently with limited supervision

Minimum requirements:
Science degree or equivalent, B.Sc./equivalent with 8 years Clinical Research (CR) experience, M.Sc./M.Pharm +6 years of clinical research (CR) experience. Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent)- PhD + 4 year of CR experience, MBBS/equivalent + 4 year of CR experience, MD +2 years of CR experience At least 5 years’ experience in medical communications as a medical writer or editor. Excellent written and oral English language skills Science degree or equivalent, B.Sc./equivalent with 8 years Clinical Research (CR) experience, M.Sc./M.Pharm +6 years of clinical research (CR) experience. Desired: Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent)- PhD + 4 year of CR experience, MBBS/equivalent + 4 year of CR experience, MD +2 years of CR experience At least 5 years’ experience in medical communications as a medical writer or editor.

Additional Information:
Job ID: 126975BR
Experience: 2-4
Location: Andhra Pradesh-Hyderabad
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: CR
End Date: 21^th Oct, 2013