Position : Manager Medical writing - Indegene Lifesystems Pvt Ltd

http://www.indegene.com/

Please email your resume to srihari.s@indegene.com

Responsible for:

• Quality and timely delivery of regulatory and safety documents.
• Supervising and mentoring team of Medical Writers to develop regulatory & safety documents.
• Building and developing additional capabilities in this place – including training and ramp-up.
  
  

Other Responsibilities:

• Work and interact extensively with clinical and regulatory experts, biostatisticians as well as external contacts.
• Ensure clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards.
• Write and review SOPs for completeness and updates as needed.
  
  

Education & Experience

• Post-graduate Medical degree or /PhD/Masters in health related/clinical field or equivalent through experience.
• Thorough knowledge of FDA, ICH and GCP guidelines regarding the submission of documents in accordance with current regulatory standards.
• Must have proven experience (minimum 4 – 5 years) as a Scientific Medical Writer in a clinical research environment and have proven experience in the management of medical documentation.
  
  

Skills needed

• Detail oriented and proficient at reviewing and editing documentation.
• Ability to read, analyze, and interpret common scientific and technical journals, reports and legal documents.
• Ability to multitask and adjust with changing priorities.
• Ability to manage multiple priorities effectively.
• Ability to coach, guide and mentor team members
• Ability to set processes in place
• Excellent time management skill.
• Willingness to work under time pressure
• Computer proficiency

If you are interested to explore certain opportunities with us, you can send across an updated CV of yours, to take the discussion forward. 

To know more about the company visit www.indegene.com

Manager Contact Info

Srihari.S
Email:srihari.s@indegene.com
Asst .Manager - Human Resource
Indegene Lifesystems Pvt Ltd
Bangalore, Mumbai, Delhi
www.indegene.com
Ph: 080 - 40787557

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