Medical Writer

Job Responsibility:

/ Roles and Responsibilities:

1) Develop protocols, informed consent forms, amendments and protocol summary documents for clinical research studies

2) Develop and incorporate research findings into clinical research reports (CSRs)/abbreviated CSR in compliance with ICH E3

3) Research and compile information from investigator brochures, product monographs, scientific literature, guidance documents, and previous clinical studies

4) Prepare responses and justifications to CTA clarifaxes, ERB inquiries and Sponsor queries

5) Apply eCTD formatting to CSRs

6) QC/copyedit protocols, informed consent forms, amendments, clinical study reports, tables and listings

7) Assist and coordinate the development of document timelines

8) Maintain protocol-related documents by seeking input and approval from required departments and review staff

9) Coordinate with other departments to generate study designs/synopses and procedures

10) Involved in review of statistical analysis plan (SAP) and mock shells

11) Properly complete documentation in accordance with GCP, SOP guidelines, and/or FDA/TPD/EMA regulations for clinical trials

12) Assist in the composition and review of validation protocols and reports

13) Work with direct manager to maintain/improve systems structure for incoming, in-process, and completed documentation in regard to traceability and version control for all Medical Writing department documentation

14) Provide guidance to junior Medical Writers

15) Other duties as required

Any Additional responsibility given by Head of the Department / Management

Qualifications:

· Minimum Bachelor's Degree

· At least 1-2 years of Medical Writing Experience as primary author of protocols, ICFs or CSRs

· Ability to produce high quality written documents

· Knowledge of ICH guidelines, regulatory guidelines and medical terminology (Preferred)

· Experience with Microsoft Office (Word and Excel) a must (REQUIRED)

· Experience with Adobe Acrobat ISI Toolbox

· Excellent written communication skills

· Strong analytical and problem solving skills

· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively.

· Excellent interpersonal skills

· Strong written and verbal communication skills

· Attention to detail

Additional Details

• 6-12 months contractual position with possibility of extension
• Work from Site is Must

Job Types: Permanent, Fixed term contractContract length: 6-12 months

Schedule:

• 8 hour shift

Education:

• Bachelor's Degree (preferred)

Experience:

• Medical Writing: 1 year (preferred)

Work Location: In person