TrentonRecruiter Since 2001
the smart solution for Trenton jobs

Associate Director Documentation Lead

Company: Bristol Myers Squibb
Location: Princeton
Posted on: April 10, 2021

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** + PhD/MD/PharmD or MS/BS with prior experience **Experience Requirements** + PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 5 years in pharmaceutical regulatory documentation, or equivalent with thorough understanding of requirements for high-level summary documents (Module 2 of CTD) **Key Competency Requirements** + Extensive experience writing clinical & regulatory documents and with registration dossiers for worldwide use + Expertise in MS WORD, including the ability to solve technical problems with WORD templates + Limited experience (ie,

Keywords: Bristol Myers Squibb, Trenton , Associate Director Documentation Lead, Executive , Princeton, New Jersey

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


MEDICAL DIRECTOR, PRIMARY CARE, LGBTQ PROGRAM
Description: MEDICAL DIRECTOR, PRIMARY CARE LGBTQ PROGRAM HACKENSACK UNIVERSITY MEDICAL CENTER Hackensack, New Jersey The Department of Internal Medicine at Hackensack University Medical Center is seeking a medical (more...)
Company: Hackensack Meridian Health
Location: Hackensack
Posted on: 04/15/2021

Associate Director, Data Partner, Global Biometrics and Data Science
Description: Associate Director, Data Partner, Global Biometrics and Data Science New Brunswick - NJ - US Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and (more...)
Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: 04/15/2021

Medical Device Sales Representative (Territory Manager), Surgical Endoscopy
Description: Working Location: PENNSYLVANIA, BREINIGSVILLE PENNSYLVANIA, CENTER VALLEY PENNSYLVANIA, STATE COLLEGE Pennsylvania, Allentown Pennsylvania, Lancaster Pennsylvania, York Are you looking for a company (more...)
Company: Olympus
Location: Lancaster
Posted on: 04/15/2021


Sr. Channel Marketing Manager, National Mass Retailers
Description: We have an opportunity for a Sr. Channel Marketing Manager who will define and execute our go-to-market strategies and tactics for a diverse set of National Retail Account customers in the home center (more...)
Company: Armstrong Flooring, Inc.
Location: Lancaster
Posted on: 04/15/2021

Branch Manager (Service Tire Truck Centers)
Description: Description: Tire Business names Service Tire Truck Centers as one of the best Tire Companies to work for in the United States in 2019. STTC offers an excellent benefit package, very competitive pay, (more...)
Company: Service Tire Truck Center Inc.
Location: West Babylon
Posted on: 04/15/2021

Vice President Diversity, Equity & Inclusion
Description: Vice President Diversity, Equity Inclusion At Lancaster General Health, our culture is what sets us apart and creates a lasting impression of our health system in the community and in the hearts of (more...)
Company: Penn Medicine Lancaster General Health
Location: Lancaster
Posted on: 04/15/2021

Digital Ad Operations Manager - WESTPORT, CT
Description: Outside TV is the leading video provider for the adventure sports and outdoor lifestyle category. Outside TV delivers high-quality, compelling storylines focused on a wide variety of sports. Our Emmy (more...)
Company: Outside TV
Location: Westport
Posted on: 04/15/2021

Licensed Medicare Insurance Agent - State of the Art Lead Management Platform
Description: Considered the gold rush of insurance, Assurance, a Prudential company, is actively looking for independent health insurance agents WITH AHIP certification Residential Insurance License required to (more...)
Company: ASSURANCE Independent Agents
Location: Mount Sinai
Posted on: 04/15/2021

Application packaging/Delivery Manager
Description: ul li Over 10 year's out of which at least 8 years
Company: InfoLogitech, Inc.
Location: Hoboken
Posted on: 04/15/2021

Assistant Meat Manager
Description: Assistant Meat Manager FULL-TIME 14.50/hr Responsible for receiving product and ensures that aisles/freezers and refrigerators are stocked, labeled, clean and delivered product is packed out, and proper (more...)
Company: Restaurant Depot
Location: Union
Posted on: 04/15/2021

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Trenton RSS job feeds