Job Title Senior
Medical Writer
Job ID 15761
City Hyderabad
Country India [IN]
Organization Overview
InVentiv Health is a global professional services
organization designed to help the biopharmaceutical industry accelerate the
delivery of much-needed therapies to market. Our combined Clinical Research
Organization (CRO) and Contract Commercial Organization (CCO) offer a
differentiated suite of services, processes and integrated solutions that
improve client performance. With more than 15,000 employees and the ability to
support clients in more than 90 countries, our global scale and deep
therapeutic expertise enable InVentiv to help clients successfully navigate an
increasingly complex environment. For more information, visit
inVentivHealth.com
Responsibilities
ü Experience
in writing, review and project management of Clinical Study Reports across the
phases and therapeutic areas
ü Should have
writing experience for Consumer Healthcare regulatory documents
ü Review of
Statistical analysis plan, Informed consent forms
ü Protocols
and amendments, Investigator’s brochure and its updates
ü Develop a
variety of documents related to regulatory, submissions, abstracts, posters,
publications, presentations, medical information letters, records, press
releases, brochures, and etc.
ü Act as lead
for assigned writing projects.
ü Manage
medical writing projects according to internal or external SOPs and client
standards, on-time, on budget and of high quality.
ü Provide
medical editing review of draft and final documents prepared by other writers
before internal or external distribution, including both copyediting and
content review.
ü Perform peer
and quality control review of medical writing documents.
ü Identify and
propose solutions to resolve issues and questions arising during the writing
process, including resolution or elevation as appropriate.
ü Initiate and
manage development of formats, templates and general guidelines for clinical
documentation and workflow procedures.
ü Keep abreast
of professional information and technology through workshops and conferences,
and ensure the appropriate transfer of that information to the department
Requirements
ü Any Life
Science graduate with relevant writing experience.
ü MS, MPH,
Pharm D, PhD, or other advanced degree is strongly preferred.
ü Minimum 6
years relevant experience in scientific, technical or medical writing
ü Hands on
experience in writing, review and project management of Clinical Study Reports
across the phases and therapeutic areas
ü Experience
writing Review of Statistical analysis plan, Informed consent forms
ü Protocols
and amendments, Investigator’s brochure and its updates
ü Proficiency
in word processing software
ü Strong
writing, editing, and organizational skills
ü Excellent
communication, presentation, interpersonal skills, both written and spoken,
with an ability to inform, influence, convince, and persuade
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