Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.
Post: Senior Medical Writer-1416209
PURPOSE
Takes a leading role in preparing or contributing to the production of most types of clinical document, for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices. Acts as mentor for less experienced Medical Writers and assists in their training and development. Participates in project teams.
RESPONSIBILITIES
• Acts as Lead Medical Writer on most types of writing project, with limited guidance from senior staff. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed. Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience.
• Reviews and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review ballpark budgets and routine costings, with management support as needed.
• May review documents or parts of documents prepared by other Medical Writers and provide appropriate feedback. Gives guidance to less experienced Medical Writers and assists in their training and development.
• May present on standard Medical Writing processes at full-service bid defence meetings by telephone or in person. May input into and deliver presentations on Medical Writing to other Quintiles groups.
• May act as Project Manager for a small stand-alone Medical Writing project (e.g. protocol or CSR). May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking.
• Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
• May propose revisions to SOPs or suggest process improvements for consideration. Complies with Company SOPs and participates in the implementation of new SOPs.
All responsibilities are essential job functions unless noted as nonessential (N).
JOB DESCRIPTION
• Ability to identify deficiencies, errors, and inconsistencies in a protocol.
• Ability to effectively review a statistical analysis plan.
• Ability to identify deficiencies, errors, and inconsistencies in statistical output.
• Developing skills in providing effective and sensitive written and verbal feedback to junior staff, and to customers when
appropriate.
• Confident and effective communication and negotiation skills with customers and project managers.
• Developing skills in chairing small meetings.
• Ability to work on several projects at once while balancing multiple and overlapping timelines.
• Ability to assess and prioritize workload.
• Demonstrated abilities in collaboration with others and independent thought.
• Knowledge of regulations relevant to medical writing.
• Careful attention to detail and accuracy.
• Must be computer literate.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
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Candidate Profile:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and
verbally.
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents.
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
• Demonstrated ability and experience to work independently on most writing projects, with limited senior guidance.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide
accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions.
• Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in a life science-related discipline, with at least 5 years' broad-ranging experience as a medical writer within a pharmaceutical environment, including lead writer roles in preparing clinical study protocols and reports; or equivalent combination of education, training and experience
Additional Information:
Experience: Min. 5 Years
Location: Bangalore and Mumbai
Education: B.Sc, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
Job Number: 1416209
End Date: 30th September, 2014
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