PURPOSE
Prepares, or contributes to the preparation of more advanced or complex clinical documents, method validation and study data reports, site manuals, or posters, for either internal Quintiles customers or external clients, for investigational drugs, biologicals, or medical devices, under the guidance of senior staff. Participates in project teams and may lead specific tasks, consulting senior staff as necessary.
RESPONSIBILITIES
Acts as Lead Medical Writer on more advanced writing projects and performs competently, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review.
Participates in both internal and external project team meetings and liaises directly with the customer on medical/technical writing issues, including setting of project timelines, as appropriate and with senior support as needed.
Facilitates appropriate internal review of assigned documents and takes responsibility for on-time delivery.
May perform QC review of documents or parts of documents prepared by more senior staff.
May deliver basic level training to small groups or individuals within Quintiles on the role of the medical/technical writing processes and specific client report templates, processes, and requests.
Takes responsibility for managing workload for assigned projects and 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.
Familiarity with the structural and content requirements of clinical or method validation and study reports, protocols, and similar documents for internal and external clients.
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
Competence in completing good first draft technical reports or clinical reports within a standard timeframe with limited guidance.
Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results.
Ability to give a presentation to a project team and/or customer on project-specific topics, e.g. on lessons learned.
Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output as related to acceptance criteria according to SOPs.
Confidence in building relationship with customer and discussing medical/technical report writing issues with customers in person, via e-mail or on the telephone.
Can provide thorough, appropriate and sensitive feedback to peers upon request to review a document.
Ability to work on several projects at once while balancing multiple and overlapping timelines.
JOB DESCRIPTION
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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/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
Bachelors degree in a life science-related discipline, communications, technical writing, or related field, with at least 2.5
years of 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
Salary:
Not Disclosed by Recruiter
Desired Candidate Profile
Education:
UG - Any Graduate - Any Specialization, BDS - Dentistry, B.Pharma - Pharmacy
PG - Any Postgraduate - Any Specialization, M.Pharma - Pharmacy
Doctorate - Any Doctorate - Any Specialization, Doctorate Not Required
Please refer to the Job description above
Company Profile
Quintiles
Quintiles (NYSE: Q) is the world"s largest provider of biopharmaceutical development and commercial outsourcing services with a network of more than 28,000 employees conducting business in approximately 100 countries. We have helped develop or commercialize all of the top-50 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit
www.quintiles.com.
