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. FRESHER
