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: RMW Group Leader (GL)
Job Description:
Job Purpose
The Group Leader is responsible for managing a team of medical writers within the Regulatory Medical Writing (RMW) function. The Group Leader collaborates with the Head, RMW India and the Global RMW Leadership team (LT) to coordinate trial/project level medical writing activities conducted for the associated program(s).
Major Activities:
1. Directly manages a team of Medical Writers in Hyderabad.
2. Performs day to day local managerial aspects, and the effective development, training and performance management of all assigned Hyderabad team members liaising with the Head, RMW India.
3. Collaborates with the RMW Project Writer(s), Global Resource Manager and other RMW Global Leads to support and ensure the flexible coordination of medical writing activities and resources of the group in Hyderabad, to deliver at the trial/project level for assigned program(s) and fill resource gaps.
4. Ensures high quality, timely communication and project information (resources, status of assigned activities, issues) flow to Head, RMW India.
5. Ensures development of assigned Group members, and builds a strong team spirit and alignment with other global RMW associates.
6. Ensures scientific/technical leadership at the trial/project level.
7. Recruits and retains talent in Hyderabad; coaches and develops associates to enable them to provide the highest levels of scientific and technical capabilities. Establishes a group founded on innovation, high performance and trust.
8. Takes an active role in (or leads) RMW initiatives, forums and contributes as a medical writer to projects and trials according to functional area of expertise.
Key Performance Indicators:
1.Achieve overall RMW goals as set each year by Head, RMW India, including operating within budget.
2.Achieve program and project goals aligned with RMW strategy.
3.All assigned RMW project deliverables conducted in Hyderabad meet targets for quality, time and cost in adherence with business standard operating procedures.
4.Achieve Talent Pipeline objectives (coaching people for high performance and high potential, building a diverse talent pool, feeding the Novartis talent pipeline, attracting and retaining the best people).
5.No critical Health Authority findings as result of routine audits.
6.Adhere to Novartis standards, in particular quality, ethical, health, safety and environment (HSE), and information security (ISEC) standards.
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Candidate Profile:
Education (minimum/desirable):
Minimum: Science degree or equivalent,
Desired – Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent)
Languages: Fluent English (oral verbal and written).
Experience/Professional requirement:
1.B.Sc./equivalent with 10 years Clinical Re-search (CR) experience, M.Sc./M.Pharm +8 years of clinical research (CR) experience PhD + 6 year of CR experience, MBBS/equivalent + 6 year of CR experience, MD +4 years of CR experience
2.Experience in clinical development, specifically in Medical Writing
3.Proven track record in successfully leading teams.
4.Demonstrated people management skills.
5.Regularly demonstrated active contributions within the line function as well as ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills.
6.Ability to work independently under pres-sure, demonstrating initiative and flexibility through effective and innovative leadership
7.Excellent interpersonal and communication skills and ability to operate effectively in a global environment
8.High level understanding of clinical devel-opment, quality, standards and policies.
9.Attention to detail and quality focused
10.Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems (e.g., MS-project) and associated processes
Additional Information:
Experience: 10 Years
Location: Hyderabad
Education: B.Pharm, M.Pharm, B.Sc, M.Sc, Ph.D, MBBS, MD
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 87672BR
End Date: 10th Nov., 2011
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