VACANCY FOR THE POST OF MANAGER, MEDICAL WRITING AT INVENTIV HEALTH, HYDERABAD

Job Title                       Manager, Medical Writing 

Job ID                          16319

City                              Hyderabad

Country                       India [IN]

Responsibilities           

ü Manage and oversee the preparation of clinical regulatory documents, which includes managing medical writing activities performed by staff writers and external writing consultants. 

ü Assist with budgeting, revenue, invoicing and forecasting as requested. 

ü Review and edit documents or sections of documents prepared by other writers (internal or contractors). 

ü Ensure adherence to client objectives and that quality standards are maintained. 

ü Support the company's medical writing leadership team in the planning, development and implementation of document development strategies. 

ü Build and maintain relationships with internal and external customers. 

ü Form, maintain, and lead productive cross-functional working teams, including addressing issues that arise. 

ü Develop templates and guidelines for clinical documentation and act as resource for implementation. 

ü Contribute to departmental metrics. 

ü Support medical writing leadership with development and presentation of quarterly business updates. 

ü Develop and maintain departmental Standard Operating Procedures (SOPs) for scientific communications services. 

ü Support business development activities by assisting with proposal and costing development as well as bid defense and customer meetings. 

ü Assist in tracking, maintaining, and reviewing project metrics.  

Requirements             

ü Bachelors Degree in Science or relevant discipline. MS, MPH, Pharm D, PhD, or other advanced degree is strongly preferred.

ü Min 8 years relevant experience in medical/technical writing within the pharmaceutical, biotechnology, or CRO industry and previous line management experience of min 2 years preferred. 

ü Knowledge of ICH guidance governing drug and document development as well as editorial and publications processes, systems and procedures. 

ü Track record of successful relationships in building and maintaining relationships with customers, both internal and external. 

ü Strong management and independent work skills; strong resource planning skills, strong written composition and editorial skills; program planning and implementation skills; and demonstrated copywriting skills