PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and approximately 19,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.
Post : Senior Medical Writer
Position Overview:
Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. Provides technical consultation and provides substantive advice on strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Job Description:
• Independently researches, writes, and edits peri-/post-approval clinical study reports, study protocols and standard response documents. Produces complex clinical or scientific documents, such as, manuscripts, posters, abstracts, oral presentation slide decks, review articles, and dossiers. Provides senior review of documents and training/mentoring for other writers.
• Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory, and other Evidera practice areas). Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
• May manage several long-term projects concurrently.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.
• Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Candidate Profile
• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Significant knowledge of global, regional, national and other document development guidelines
• In-depth knowledge in a specialty area such as therapeutic, regulatory submissions, healthcare communications, etc.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
• Aptitude to accurately work with, manipulate and format numbers, numerical information, and data of various types to provide evidence, information, and insights
• Demonstrated ability to communicate and document information effectively in written English, including the ability to produce reports, documents, emails and other written pieces which are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience
• Able to analyze complex issues and evidence, identify cause-effect relationships, and generate effective solutions.
• Able to create, communicate, and manage effective project plans that support the delivery of overall project objective(s); to identify, manage and guide project team members; to monitor and report on progress in an organized fashion; and to deliver the required results.
• Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.
• Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropriate course of action, and following up to ensure a successful outcome.
Additional Information
Experience : 5+
Qualification : B.Pharm, B.Sc, M.Sc, M.Pharm
Location : New Delhi
Industry Type : Pharma
Functional Area : Medical Writer
End Date : 20th February, 2019
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