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 Writing Documnt Spec 1-1721698
Job Description:
PURPOSE
Supports the preparation of study reports, submissions, or other documents for either internal Quintiles customers or external clients by providing quality control review, collecting appendices for documents, document preparation and publishing, and providing general assistance with document compilation. May participate in project teams, consulting senior staff as necessary.
RESPONSIBILITIES
• Perform quality control review of documents of medium complexity (eg, clinical study reports [CSRs], protocols, and patient narratives) to ensure accuracy and internal consistency according to Quintiles SOPs Perform document preparation and publishing to ensure accuracy and compliance with ICH guidelines and regional health authorities
• Collect CSR appendices in accordance with ICH guidelines and Quintiles standard practices, with limited guidance from the lead medical writer for the CSR
• Take responsibility for on-time delivery of QC review and appendix collection
• Support the collection of service metrics, as needed
• Support the development of quality tools such as checklist, quality guidelines, standards and scoring methodology to meet project specific needs , consulting senior staff as necessary
• Take responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff
• Help identify quality issues and bring awareness to senior staff
• Keep abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing/regulatory submissions
• Comply with Company SOPs and participate in the implementation of new SOPs
• May assist with delivery or development of basic training to small groups or individuals within Quintiles
• May address technical issues with documents and applications and offer assistance to staff.
• May support the computer system validation of sofware and applications, consulting senior staff as necessary
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- 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.
- Ability to assist with development and execution of training within Quintiles
- Ability to understand scientific/medical documents and identify deficiencies, errors and inconsistencies
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents
- 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 and regulatory submissions
- Must be computer literate
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
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Candidate Profile
Bachelor’s degree in a life science-related discipline, with 1 years' experience QC review or preparation of documents within a pharmaceutical environment; or equivalent combination of education, training and experience
PHYSICAL REQUIREMENTS
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Additional Information:
Experience: 1-2 years
Location: Maharashtra-Mumbai
Education: B.Pharm, M.Pharm, B.Sc, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
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