Job Family Description
Writes, reviews, and coordinates preparation of clinical trial documentation in line with client specifications and industry practices.
Prepares, or contributes to the preparation of clinical and regulatory documents for external clients, for investigational drugs, biologicals, or medical devices.
Collaborates with internal and external experts and specialists and maintains expertise on developments in a particular field of focus.
Job Profile Summary
An entry level role within a structured program, supporting Medical Writing deliverables and focusing on specific tasks under senior supervision, while gaining experience, knowledge, and skills in Medical Writing.
Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in drug development/medical and/or technical writing.
Gain knowledge, experience, and competence in specific Medical Writing tasks by supporting Medical Writing senior staff in managing client requests under supervision, focusing on tasks such as writing patient narratives.
Manage day-to-day workload, track timelines, draft assigned documents to a high standard, and implement review comments and customer requests with senior guidance/review, keeping manager/senior staff abreast of progress on tasks and any potential problems.
Interact with internal clients. May have some external interactions, mostly directed by senior staff.
Keep 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.
Comply with customer requirements and with IQVIA SOPs and standards.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This is an entry level trainee position and as such education, skills, and potential are more important than formal work experience. However, experience and strong ability in scientific writing in English gained from academic studies or work experience is essential.
Awareness of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
Bachelor’s Degree (BAMS, BHMS, BDS)
Life science-related discipline or related field
Advanced Degree (MPharm, MSc or PhD)
Life science-related discipline or related field
Additional Work Experience
Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
Skills and Abilities
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention to detail and accuracy.
- Communicates clearly, effectively and confidently with others.
- Demonstrated abilities in collaboration with others and independent thought.
- Demonstrates confidence and maturity in most routine medical writing situations.
- Demonstrates good judgement in requesting input from senior staff.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
- Ability to effectively manage multiple tasks and projects.
- Must be computer literate.
Standard ADA Settings
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Standard ADA Selection
- 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.
May require occasional travel.
The above information on this description has been designed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job. While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at referrals.iqvia.com
Thane, Maharashtra, India
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