Opening for the Position of Medical Writing Document Assoc @ Quintiles
Job Description
Dear candidate
We have an urgent opening for the position of Medical Writing Document Assoc:
Looking for candidate with 1 yr+ experience on Medical Writing.
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
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
Click here to apply
Job Description
Dear candidate
We have an urgent opening for the position of Medical Writing Document Assoc:
Looking for candidate with 1 yr+ experience on Medical Writing.
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
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
Click here to apply
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