PURPOSE
Assists senior
medical writing
staff in the preparation of study reports, submissions, or other
documents for either internal Quintiles customers or external clients,
for investigational drugs, biologicals, or
medical
devices. Participates in project teams and may lead specific
straightforward or small tasks, consulting senior staff as necessary.
RESPONSIBILITIES
Supports
Medical Writing senior staff in managing client requests. Examples include but are not limited to the following:
writing
patient narratives, straightforward bioanalytical study data reports,
checking document edits, checking documents for consistency, adapting
generic document shells to project specifications, assisting with
document compilation, and entering numbers into in-text tables. May also
draft text for simple documents, reports or sections of documents or
reports, with guidance of senior staff.
Identifies project needs, tracks project timelines and implements client requests, with senior review.
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 and/or technical
writing/regulatory knowledge, developments and advances in area of drug development/
medical and/or technical
writing.
Complies with Company SOPs and participates in the implementation of new SOPs.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in
writing and verbally.
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/technical
writing, such as Good Laboratory Practices (GLP) and other relevant regulatory agencies (e.g. OECD, MHLW).
Careful attention to detail and accuracy.
Must be computer literate.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Dentistry / BHAMS / M-Pharm with post-graduation in clinical
research.Bachelors degree in a life science-related discipline,
communications, technical
writing, or related field; or equivalent combination of education, training and experience. 1 - 2 years experience in
Medical Writing.
