INC Research is a top-tier therapeutically focused global clinical research organization (CRO) providing a complete range of Phase I – Phase IV clinical development services for the world’s biopharmaceutical companies. We proudly boast 43 of the world’s top 50 pharmaceutical companies as our customers. With approximately 5,000 employees across six continents and experience spanning more than 100 countries, we provide significant scale, scope and expertise to deliver innovative clinical development approaches and strategic alliances that meet the needs of our customers.
Post: Manager, Medical Writing
Job Description
Responsible for the task-specific supervision of the medical writing staff members. Coordinates medical writing activities to ensure satisfactory completion of all writing projects. Essential Functions:
• Project-specific management responsibilities for staff members. Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Reviews departmental work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products.
• Assists with the preparation of budgets and timelines for medical writing activities for full-service clinical development projects and for stand-alone medical writing projects as needed.
• Serves as a member of the department management team for all projects requiring report writing.
• Reviews performance of medical writing personnel (direct reports).
• Plans, writes, and assembles clinical study reports, manuscripts, and regulatory submissions, as needed.
• Participates in the development of protocols, investigator’s brochures, and other study documents, as needed.
• Reviews statistical analysis plans and table/figure/listing specifications for grammar, format, and consistency. Other Responsibilities:
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
Candidate Profile
BS degree in life sciences or equivalent related education and experience. Extensive experience in medical writing that includes work in a contract research organization. Management experience preferred.
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines. Familiarity with principles of clinical research including ability to present and interpret clinical data appropriately.
Highly effective presentation, interpersonal, and leadership skills with a team-oriented approach. Strong Microsoft Office Suite skills.
Additional Information:
Qualification : BS degree in life sciences
Location : Gurgaon
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : Medical Writing
Last date : 23rd August, 2016
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