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: Medical Writer 1-1403379
Job Description
PURPOSE
Prepares, or contributes to the preparation of straightforward clinical documents, for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff. Participates in project teams and may lead specific tasks, consulting senior staff as necessary.
Prepares, or contributes to the preparation of straightforward clinical documents, for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff. Participates in project teams and may lead specific tasks, consulting senior staff as necessary.
RESPONSIBILITIES
• Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with
Quintiles SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review.
• 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.
• Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
• May perform QC review of documents or parts of documents prepared by more senior staff.
• Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff.
• Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
• Complies with Company SOPs and participates in the implementation of new SOPs.
• Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with
Quintiles SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review.
• 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.
• Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
• May perform QC review of documents or parts of documents prepared by more senior staff.
• Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff.
• Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
• Complies with Company SOPs and participates in the implementation of new SOPs.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
• Familiarity with 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.
• Competence in completing a good first draft clinical study report in a routine therapeutic area within a reasonable time frame with limited guidance.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Ability to give a simple presentation to a project team and/or customer, e.g. on Medical Writing processes.
• Ability to identify inconsistencies and deficiencies in statistical output.
• Ability to work on several projects at once while balancing multiple and overlapping timelines.
• Ability to assess workload and suggest prioritization to senior staff.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrates confidence and maturity in most routine Medical Writing situations.
• Behaves professionally and responds appropriately to feedback from internal and external sources.
• Knowledge of regulations relevant to medical writing.
• Careful attention to detail and accuracy.
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
• Familiarity with 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.
• Competence in completing a good first draft clinical study report in a routine therapeutic area within a reasonable time frame with limited guidance.
• Good understanding of common statistical methods used in clinical trials and interpretation of their results.
• Ability to give a simple presentation to a project team and/or customer, e.g. on Medical Writing processes.
• Ability to identify inconsistencies and deficiencies in statistical output.
• Ability to work on several projects at once while balancing multiple and overlapping timelines.
• Ability to assess workload and suggest prioritization to senior staff.
• Demonstrated abilities in collaboration with others and independent thought.
• Demonstrates confidence and maturity in most routine Medical Writing situations.
• Behaves professionally and responds appropriately to feedback from internal and external sources.
• Knowledge of regulations relevant to medical writing.
• Careful attention to detail and accuracy.
Candidate Profile
• Must be computer literate.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Must be computer literate.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor's degree in a life science-related discipline, plus at least 2years+ experience as a medical writer within a pharmaceutical environment; or equivalent combination of education, training and experience
Additional Information:
Experience: 2+ years
Location: Mumbai, Maharashtra
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
Job Code: 1409912
End Date: 30th June, 2014
Experience: 2+ years
Location: Mumbai, Maharashtra
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
Job Code: 1409912
End Date: 30th June, 2014
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