Bristol-Myers Squibb Company

Senior Safety Narratives Coordinator

Location
Lawrence Township, NJ, United States
Posted
Aug 09, 2019
Ref
R1516452
Required Education
Doctorate/PHD/MD
Position Type
Full time
Purpose

To coordinate the preparation of safety narratives required for inclusion in clinical study reports by contributing to their planning, writing, reviewing and presentation.

Key Responsibilities and Major Duties

Contribute to and maintain the plans for preparation of safety narratives for individual studies in collaboration with the medical and writing teams

Oversee and manage the narrative preparation process from initial drafts through finalization and incorporation into the clinical study report

Review and QC the scientific content of safety narratives for compliance with ICH guidelines and regulatory requirements

Edit safety narratives so that they adhere to good writing practices

Properly format and finalize narrative appendices for incorporation into the clinical study report

List of Minimum Requirements

Degree/Certification/Licensure

Graduate (BS) level degree plus sufficient experience or post-graduate level degree in a patient-based, health-related discipline, such as nursing, pharmacy, psychology

Experience - Responsibility and minimum number of years

Bachelor-level degree, with at least 8 years of practical experience, including at least 3 years of direct clinical experience, i.e., patient contact, or graduate-level degree, with at least 3 years of direct clinical experience, i.e., patient contact

Three or more years of pharma industry experience such as in medical writing, pharmacovigilance, clinical research/operations, or regulatory affairs

Drug safety knowledge and experience, a plus

Competencies - knowledge, skills, abilities, other

Oral and written Fluency in English

Able to work in a matrixed environment

Familiarity working in regulated environments

Ability to work efficiently under strict timelines

Ability to recognize inconsistency or gaps in medical summaries, and query and/or rewrite appropriately.