Associate Director Documentation Lead
Company: Adecco Group
Location: Berkeley Heights
Posted on: February 25, 2021
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Job Description:
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science.--In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference. Position Summary /
Objective Provides strategic direction and effectively drives the
development and implementation of regulatory documentation strategy
to deliver key R&D business objectives, supports "speed to
patient", and facilitates submissions and approvals in key defined
markets within global commercial geographic footprint Aligns with
governance on prioritization and execution of documentation
submission strategy Position Responsibilities Act as Medical
Writing submission lead, driving content and strategy of clinical
documents. Lead document prototyping and preparation processes to
ensure: coordination and efficient use of messages between internal
development plans, IND and NDA documentation, and appropriate
prioritization of critical versus non-critical path activities
Drive the development and manage the implementation of regulatory
documentation strategy to meet time and quality performance goals
for filing regulatory dossiers as planned by Development Teams
Coordinate documentation activities of multi-functional authors and
reviewers from discovery, pharmaceutical development, clinical
discovery, development and life-cycle management; and manage the
document review process to maximize speed and quality on behalf of
the assigned development team(s) Ensure documentation strategy is
integrated to support filings, approvals and/or other regulatory
commitments in the intended key markets Contribute to the
development of effective documentation processes and standards;
implement the processes to support goals of assigned development
team(s) and ensure maintenance of PRI documentation standards
Critically review project-specific model documents, key data texts
and displays during dossier prototype creation and facilitate
reaching a consensus at key findings/ final document review meeting
Influence the assigned development team(s) in tracking milestone
activities and proactively identify any issue(s), particularly the
ones with a potential to impact the dossier quality or timelines In
conjunction with the team members, manage and coordinate responses
to dossier-related health authority questions In conjunction with
appropriate disciplines, identify and ensure management of external
documentation support when required Participate in project and/or
functional leadership opportunities, such as project-wide advisory
role in FDT; Align with GCR, GBS and Regulatory TA Heads on overall
messages and deliverables Degree Requirements
Keywords: Adecco Group, New York , Associate Director Documentation Lead, Executive , Berkeley Heights, New York
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