Opening for Medical Writing Document Associate @ Quintiles
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 o f healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Medical Writing Document Assoc-1507689
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, and providing general assistance with document compilation.
RESPONSIBILITIES
- Performs quality control review of documents of simple complexity (eg, model reports 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
- Assists with the collection of CSR appendices in accordance with ICH guidelines and Quintiles standard practices, with guidance from the lead medical writer for the CSR
- Interacts with internal clients. May have some external interactions, mostly directed by senior staff
- Takes responsibility for managing day-to-day workload for assigned tasks, 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/regulatory submissions
- Complies with Company SOPs and participates in the implementation of new SOPs
- May address technical issues with documents and applications and offer assistance to staff
All responsibilities are essential job functions unless noted as nonessential (N).
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 understand scientific/medical documents and identify deficiencies, errors and inconsistencies
- 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
- 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
Candidate Profile
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- High School diploma with 5 years’ experience in a medical, clinical, preclinical, chemistry or related 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: 5 years
Location: Bangalore- Karnataka
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
End Date: 30th May, 2015
Click here to apply
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 o f healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Post: Medical Writing Document Assoc-1507689
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, and providing general assistance with document compilation.
RESPONSIBILITIES
- Performs quality control review of documents of simple complexity (eg, model reports 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
- Assists with the collection of CSR appendices in accordance with ICH guidelines and Quintiles standard practices, with guidance from the lead medical writer for the CSR
- Interacts with internal clients. May have some external interactions, mostly directed by senior staff
- Takes responsibility for managing day-to-day workload for assigned tasks, 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/regulatory submissions
- Complies with Company SOPs and participates in the implementation of new SOPs
- May address technical issues with documents and applications and offer assistance to staff
All responsibilities are essential job functions unless noted as nonessential (N).
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 understand scientific/medical documents and identify deficiencies, errors and inconsistencies
- 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
- 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
Candidate Profile
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- High School diploma with 5 years’ experience in a medical, clinical, preclinical, chemistry or related 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: 5 years
Location: Bangalore- Karnataka
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
End Date: 30th May, 2015
Click here to apply
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