PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
Post : Mgr Med Writing (Clinical Documentation)
This position manages the performance and workload of Medical Writers and provides short-term and long-term resource planning in order to assign projects to appropriate and available staff. Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluates timeliness and quality of deliverables. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Participates in preparation and review of group SOPs and WPDs. Evaluates compliance with SOP/WPD on an ongoing basis. Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare budgets and proposals for Medical Writing projects.Participates in the development of training programs for Medical Writing. Ensures direct reports are adequately trained.
• Supervises Medical Writers. Provide short-term and long-term resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve semimonthly time sheets. Assist staff to forecast project-related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions
• Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on the guidelines and requirements of the ICH, FDA and other relevant agencies.
• Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare proposals for Medical Writing projects.
• Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained.
• Uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data.
• Writes and coordinates other documents for submission to regulatory agencies, including IND, NDA, and CTD items.
• Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent and relevant combination of education, training, & experience. 2 years relevant experience in medical writing, preferably within the pharmaceutical industry
• 1+ year of leadership responsibility Years of experience refers to typical years of related experience needed to gain the required knowledge, skills,and abilities necessary to perform the essential functionsof the job.Years of experience arenottobe used as theonly determining factor in establishing the job classor making employment selection decisions.
• Ability to supervise, evaluate, and mentor departmental personnel
• Ability to oversee assignments, monitor staff workload, and provide guidance for completion of assignments
• Ability to create and modify project timelines, allocate resources, and forecast departmental workload
• In depth knowledge of departmental processes and ability to contribute to improving and developing processes
• Excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present extremely complex data
• Effective communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits
• Ability to develop, review, and modify proposals and budgets for presentation to clients
Experience : 5+ years
Qualification : Bachelor’s degree, PharmD, PhD, Masters
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Documentation
End Date : 30th September, 2021
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