• Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role.
United States Jobs Expertini

Production - Documentation Analyst Job Opening In New Brunswick – Now Hiring Mindlance


Job description

Job Description:
o Documentation Analyst will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO).

This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.

o This role requires effective collaboration across technical functions to deliver on timelines for submissions.

The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO.

The successful candidate will work effectively in cross-functional project teams to accomplish company goals.



• Primary Responsibilities:

o Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical and life-cycle CMC regulatory submissions and responses to health authority questions.

o Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, address any grammatical or formatting related comments.

o Facilitate and manage the data verification process.

o Assist with dossier creation and system compliance for regulatory submissions

o Track upcoming submissions and ongoing submission progress

o Represent Tech Writing and Document management in cross-functional CMC teams as required.

o Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.

o Collaborate with external suppliers as needed for CTD content and review.

o Support and implement continuous process improvement ideas and initiatives.

o Train others on procedures, systems access and best practices as appropriate.

o Mentor and train employees on the document management process

o Work independently under supervision and collaborate with other teams.



• Competencies & Experiences

o Required Bachelor’s degree in Biology or related discipline with a minimum of + years experience

o Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.

o Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.

o Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.

o Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.

o Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.

o Experience in bio tech/pharma ee product development required.

Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.

o Take ownership of the section – formatting, language check, connections to other sections / tables.

o Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy.



Travel: Occasionally to other local NJ sites for larger team times a year)



EEO:



Required Skill Profession

Business Operations Specialists


  • Job Details

Related Jobs

Sunrise Systems hiring Documentation Analyst Job in New Brunswick, New Jersey, United States
Sunrise Systems
New Brunswick, New Jersey, United States
Sunrise Systems Inc hiring Documentation Analyst Job in New Brunswick, New Jersey, , United States
Sunrise Systems Inc
New Brunswick, New Jersey, , United States
BAE Systems hiring Documentation Control Analyst Job in Hudson, NH, United States
BAE Systems
Hudson, NH, United States
Emerson hiring Quality Documentation Analyst Job in Marshalltown, IA, United States
Emerson
Marshalltown, IA, United States
Future Tech Enterprise, Inc. hiring Compliance Documentation Analyst Job in , REMOTE, United States
Future Tech Enterprise, Inc.
, REMOTE, United States
TriTech Enterprise Systems, Inc. hiring Compliance / Documentation Analyst Job in Linthicum, MD, United States
TriTech Enterprise Systems, Inc.
Linthicum, MD, United States
eTeam Inc. hiring Tax Documentation - Analyst Job in Salt Lake City, Utah, , United States
eTeam Inc.
Salt Lake City, Utah, , United States
Citi hiring Loan Documentation & Processing Senior Analyst Job in New Castle, Delaware, United States
Citi
New Castle, Delaware, United States
ProSidian Consulting, LLC hiring Nuclear Safety Documentation Analyst [DOE0114113] Job in Richland, Washington, United States
ProSidian Consulting, LLC
Richland, Washington, United States
Citigroup hiring Loan Documentation & Processing Senior Analyst Job in New Castle, DE, United States
Citigroup
New Castle, DE, United States
Bimbo Bakeries USA hiring Production Analyst Job in Mattoon, Illinois, United States
Bimbo Bakeries USA
Mattoon, Illinois, United States
Onward Search hiring Production Analyst Job in Chicago, Illinois, United States
Onward Search
Chicago, Illinois, United States
BlueOval SK hiring Production Analyst Job in Glendale, KY, United States
BlueOval SK
Glendale, KY, United States
Goldman Sachs hiring GBM - Private Dept-Documentation Analyst- Dallas Job in Dallas, Texas, United States
Goldman Sachs
Dallas, Texas, United States
00002 Citibank, N.A. hiring Loan Documentation and Processing Associate Analyst Job in New Castle, Delaware, United States
00002 Citibank, N.A.
New Castle, Delaware, United States
CommonSpirit Health hiring Supply Chain Communications and Documentation Analyst Job in Phoenix, AZ, United States
CommonSpirit Health
Phoenix, AZ, United States
CommonSpirit Health hiring Supply Chain Communications and Documentation Analyst Job in Phoenix, AZ, United States
CommonSpirit Health
Phoenix, AZ, United States
Citigroup hiring Loan Documentation and Processing Associate Analyst Job in New Castle, DE, United States
Citigroup
New Castle, DE, United States
Citigroup hiring Loan Documentation and Processing Associate Analyst Job in New Castle, DE, United States
Citigroup
New Castle, DE, United States
CAREERXCHANGE, Inc. hiring Documentation Specialist Job in Miami, Florida, United States
CAREERXCHANGE, Inc.
Miami, Florida, United States
Kelly Services hiring Documentation Specialist Job in Kemmerer, Wyoming, United States
Kelly Services
Kemmerer, Wyoming, United States
Amphenol ICC hiring Documentation Manager Job in Hamden, Connecticut, United States
Amphenol ICC
Hamden, Connecticut, United States
FusionAuth hiring Documentation Engineer Job in Denver, Colorado, United States
FusionAuth
Denver, Colorado, United States
PrimeCare Orthotics & Prosthetics hiring Documentation Specialist Job in Las Cruces, New Mexico, United States
PrimeCare Orthotics & Prosthetics
Las Cruces, New Mexico, United States
Catalyx hiring Documentation Specialist Job in United States
Catalyx
United States
Apex Systems hiring Documentation Specialist Job in Waynesboro, Georgia, United States
Apex Systems
Waynesboro, Georgia, United States
Tropical Shipping hiring Documentation Specialist Job in Miami, Florida, United States
Tropical Shipping
Miami, Florida, United States
CCS Medical hiring Documentation Rep Job in Dallas, Texas, United States
CCS Medical
Dallas, Texas, United States
AdaptHealth hiring Documentation Specialist Job in Chula Vista, California, United States
AdaptHealth
Chula Vista, California, United States
Quantaleap hiring Documentation Specialist Job in Baton Rouge, Louisiana, United States
Quantaleap
Baton Rouge, Louisiana, United States
Strategic Risk Solutions hiring Documentation Specialist Job in Concord, Massachusetts, United States
Strategic Risk Solutions
Concord, Massachusetts, United States

Unlock Your Production Documentation Potential: Insight & Career Growth Guide


Real-time Production Documentation Jobs Trends (Graphical Representation)

Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph here. Uncover the dynamic job market trends for Production Documentation in New Brunswick, United States, highlighting market share and opportunities for professionals in Production Documentation roles.

18299 Jobs in United States
18299
442 Jobs in New Brunswick
442
Download Production Documentation Jobs Trends in New Brunswick and United States

Are You Looking for Production Documentation Analyst Job?

Great news! is currently hiring and seeking a Production Documentation Analyst to join their team. Feel free to download the job details.

Wait no longer! Are you also interested in exploring similar jobs? Search now: .

The Work Culture

An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Mindlance adheres to the cultural norms as outlined by Expertini.

The fundamental ethical values are:

1. Independence

2. Loyalty

3. Impartiapty

4. Integrity

5. Accountabipty

6. Respect for human rights

7. Obeying United States laws and regulations

What Is the Average Salary Range for Production Documentation Analyst Positions?

The average salary range for a varies, but the pay scale is rated "Standard" in New Brunswick. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

What Are the Key Qualifications for Production Documentation Analyst?

Key qualifications for Production Documentation Analyst typically include Business Operations Specialists and a list of qualifications and expertise as mentioned in the job specification. The generic skills are mostly outlined by the . Be sure to check the specific job listing for detailed requirements and qualifications.

How Can I Improve My Chances of Getting Hired for Production Documentation Analyst?

To improve your chances of getting hired for Production Documentation Analyst, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

Interview Tips for Production Documentation Analyst Job Success

Mindlance interview tips for Production   Documentation Analyst

Here are some tips to help you prepare for and ace your Production Documentation Analyst job interview:

Before the Interview:

Research: Learn about the Mindlance's mission, values, products, and the specific job requirements and get further information about

Other Openings

Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.

Dress Professionally: Choose attire appropriate for the company culture.

Prepare Questions: Show your interest by having thoughtful questions for the interviewer.

Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.

During the Interview:

Be Punctual: Arrive on time to demonstrate professionalism and respect.

Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.

Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.

Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.

Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.

Follow Up: Send a thank-you email to the interviewer within 24 hours.

Additional Tips:

Be Yourself: Let your personality shine through while maintaining professionalism.

Be Honest: Don't exaggerate your skills or experience.

Be Positive: Focus on your strengths and accomplishments.

Body Language: Maintain good posture, avoid fidgeting, and make eye contact.

Turn Off Phone: Avoid distractions during the interview.

Final Thought:

To prepare for your Production Documentation Analyst interview at Mindlance, research the company, understand the job requirements, and practice common interview questions.

Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Mindlance's products or services and be prepared to discuss how you can contribute to their success.

By following these tips, you can increase your chances of making a positive impression and landing the job!

How to Set Up Job Alerts for Production Documentation Analyst Positions

Setting up job alerts for Production Documentation Analyst is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!