Medical Writer and Senior Medical Writer

1 week ago

Johannesburg South, South Africa Arborvitae.in Full time

ROLE: Medical Writer and Senior Medical Writer

EDUCATION: Medical/M.Pharm/Pharm D/life sciences degree.

EXPERIENCE:

- Minimum 2-4 years’ experience in medical/regulatory writing for A3 and 4-6 years for A4 or

equivalent experience in the life sciences domain.
- Relevant experience in regulatory writing
- Knowledge of regulatory documentation, drug development process and global regulations and

guidelines.

ROLE PURPOSE: Responsible for authoring/preparing submission readiness/QC of

regulatory/clinical/safety documents.

SKILLS:

- Experienced in authoring multiple clinical study reports (CSRs), protocols, amendments, and

Investigator Brochures (IBs); experience in writing some clinical summary documents (Module

2.5, 2.7) preferred
- Able to work independently while maintaining communication with the Sponsor’s MW project

manager
- Ability to develop, coordinate, and oversee work plans for both individual and multiple
- document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and

responsibilities that enable the team to work efficiently and effectively to deliver all milestone

tasks and documents within specified timelines
- Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses

data interpretation, product claims, and internal/external questions

Outlook, Word).
- Knowledge of regulatory documentation, drug development and global regulations and

guidelines.
- Good written and verbal communication skills.
- Good organizational and time management skills.
- Good attention to detail and decision-making skills.

PRINCIPAL RESPONSIBILITIES:

- Responsible for authoring regulatory documents like Clinical Overviews, Investigator Brochures,

HA responses, etc, incorporation of review comments, tracking, communication and coordinating

with QC process, submission-readiness activities of simple and medium complexity documents.
- Discuss project details and obtain clarification on specific questions/issues/gaps with project

POC.
- Perform peer review to validate accuracy and relevance of the data presented in the documents

against the source data or references used in the document.
- Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data,

missing data, improper sentence structuring, inconsistency of data (text/number) within the

document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style).
- Assist senior medical writers in authoring medium/complex deliverable types.
- Obtain references from library and link to the document.
- Formatting word documents as per the client -specific style guide - creation of TOC, list of

abbreviations, formatting of tables and figures for consistency in font, alignment, foot note

references, portrait and landscape adjustments, endnotes and cross referencing.
- Formatting PDF documents in Adobe Acrobat and ISI Toolbox, cross referencing, pagination,

bookmarking and hyper-linking.
- Perform reference request task.
- Responsible for the entire life cycle of the document and accountable for maintaining quality and

timeliness, and compliance to internal/client SOPs and regulations.
- Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines

and are in accordance with electronic publishing standards.

**Job Types**: Full-time, Permanent

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