Principal Medical Writer

6 months ago

Mumbai Maharashtra, India Abbott Laboratories Full time

**Primary Job Function**:

- Manage the quality, accuracy, compliance with internal & external standards and the timely production of documents
- Point of Contact for all medical writing/publishing activities for affiliate.
- Responsible for quality and timelines of all publications.
- Develop, implement and manage templates & documentation format required for standardization of regulatory & clinical documentation as per SOPs.
- Participate in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide & poster presentations.
- Coordinate and conduct interdepartmental team review and sign-off of document deliverables according to guidelines/SOPs including: distribute drafts, chair review meetings, incorporate revisions, document key project events and complete sign-off procedures.
- Create/maintain audit system/trails of all document changes.
- Use scientific expertise to develop high-quality, publication-ready scientific documents (manuscripts, posters, abstracts, short communications, presentations, etc.)
- Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
- Be familiar with and work in accordance with Schedule Y, Good Clinical Practices and ICH guidelines and Standard Operating Procedures.
- Perform literature searches/reviews as necessary to obtain background information for development of documents.
- Responsible for review and approval of all new medical writing vendors.

**Additional responsibilities**:

- Manage the writing, editing and reviewing of clinical documents including clinical study concept, protocol synopsis, clinical study reports (CSRs), study protocols, investigator brochures, informed consent forms, clinical data summaries, and other medical documents

**Core Job Responsibilities**:

- Serve as the primary medical writing representative on assigned Project teams and closely collaborate with personnel from clinical, regulatory and Medical departments.
- Medical writing activities that support the preparation of clinical documents required to support a) Registration of products b) Generate Scientific Evidence for Established products. ie Protocols, CRFs, ICFs, CSRs and manuscripts.
- Will be accountable for ensuring Local legislation, ICH-GCP guidelines, Abbott EPD and Indian clinical research guidelines are maintained and followed in writing for all studies.

**Supervisory/Management Responsibilities**:
**Direct Reports**:NA

**Indirect Reports**:NA

**Position Accountability/Scope**:

- Medical Writer will report to Associate Director - Clinical Development, who in turn will report to the Area Medical Director.

**Minimum Education**:
MD/PhD/MBBS/M. Pharm/ B. Pharm/MSc/BSc

**Minimum Experience/Training Required**:

- Minimum 8 years of medical writing work exp. in clinical research in CRO or pharmaceutical Company

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