Talent.com
Pharma Technical Writer

Pharma Technical Writer

MediabistroNew Brunswick, NJ, United States
4 days ago
Job type
  • Full-time
Job description

Job Title : Pharma Technical Writer Location : New Brunswick, NJ Hours / Schedule : Mon-Friday (normal business hours) Compensation : $34.87- $44.29 Type : Contract Overview Leading pharmaceutical company looking for an experienced Technical Writer. Ideal candidates should have at least 2 years of experience specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry. Responsibilities Co-authors / authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports. Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets. Manage the logistical process and detailed timeline for regulatory submissions. Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy. Provide input and scientific oversight for content generation for Module 2.3 and 3. Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections. Ensures content clarity / consistency in messaging across dossier. Facilitate and manage the data verification process. Assist with dossier creation and system compliance for regulatory submissions Coordinate response authoring, review and data verification to queries from HA for submissions. Track upcoming submissions and ongoing submission progress Maintain submission content tracker for regulatory submissions and work with doc specialist / PM / Reg CMC to update tracker. Represent Tech Writing and Document management in cross-functional CMC teams as required. Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions. Collaborate with external suppliers as needed for CTD content and review. Support and implement continuous process improvement ideas and initiatives. Train others on procedures, systems access and best practices as appropriate. Mentor and train employees on the document management process Work independently under supervision and collaborate with other teams. Requirements Required Bachelor’s degree in Biology or related discipline with a minimum of 2 years’ experience Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required. Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred. Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery. Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required. Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication. Experience in bio tech / pharma e2e product development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines. Take ownership of the section – formatting, language check, connections to other sections / tables. Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy. Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan. Ref : #558-Scientific

Create a job alert for this search

Technical Writer • New Brunswick, NJ, United States

Related jobs
Technical Writer Job at Integrated Resources in New Brunswick

Technical Writer Job at Integrated Resources in New Brunswick

MediabistroNew Brunswick, NJ, United States
Full-time
Location : New Brunswick, NJ - 50% Remote role.Duration : 12 Months+ (Possibility of Extension).The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strat...Show moreLast updated: 6 days ago
Aquestive Therapeutics is hiring : Regulatory Technical Writer in Warren

Aquestive Therapeutics is hiring : Regulatory Technical Writer in Warren

MediabistroWarren, NJ, United States
Full-time
We are seeking a highly skilled Principal Regulatory Medical Writer to lead and contribute to key regulatory documentation efforts. The ideal candidate will have 4-8 years of experience in regulator...Show moreLast updated: 30+ days ago
  • Promoted
Technical Writer

Technical Writer

TradeJobsWorkForce10162 New York, NY, US
Full-time
Research, write, edit and proofread complex technical data.Create, maintain and update manuals, procedures, specifications and other documents. Create, maintain and update installation instructions,...Show moreLast updated: 30+ days ago
Technical writing with labelling & Pharma Job at Dawar Consulting in Somerville

Technical writing with labelling & Pharma Job at Dawar Consulting in Somerville

MediabistroSomerville, NJ, United States
Temporary
Our client, a world leader in diagnostics and life sciences, is looking for a.Long Term Contract (Possibility Of Further Extension). Company Benefits : Medical, Dental, Vision, Paid Sick leave, 401K....Show moreLast updated: 6 days ago
  • Promoted
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor

Syneos Health / inVentiv Health Commercial LLCBridgewater, NJ, United States
Full-time
Senior Principal Medical Writer - Regulatory - Oncology - Single Sponsor.Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We...Show moreLast updated: 11 days ago
  • New!
Technical Writer

Technical Writer

MediabistroBranchburg, NJ, United States
Temporary
Title : Technical Writer Med / Clin I.Duration : 12 months contract (High Chances of Extension).As a Technical Writer in the Operations Labeling Group, you will be responsible for creating, revising, a...Show moreLast updated: less than 1 hour ago
Technical Writer Job at Advanced Clinical in Somerville

Technical Writer Job at Advanced Clinical in Somerville

MediabistroSomerville, NJ, United States
Full-time
We are currently searching for a skilled professional to join a well-known client’s team as a Technical Writer in Branchburg, New Jersey. The Technical Writer role will be responsible for creating, ...Show moreLast updated: 4 days ago
  • Promoted
Technical Writer

Technical Writer

EquiLendNew York, NY, US
Full-time
We are a a global financial technology firm serving over 200 of the world's leading financial institutions, including asset owners, broker-dealers, hedge funds, and lending banks.Since launchin...Show moreLast updated: 11 days ago
Technical Writer - CMC Regulatory Submissions (Hybrid, New Brunswick)

Technical Writer - CMC Regulatory Submissions (Hybrid, New Brunswick)

SOKOL GxP ServicesNew Brunswick, NJ, US
Temporary
Quick Apply
SOKOL GxP Services is hiring a Technical Writer – CMC Regulatory Submissions.This hybrid role will be part of the.Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (P...Show moreLast updated: 22 days ago
Technical Writer

Technical Writer

Sunrise SystemsWarren, New Jersey, United States
Temporary
Quick Apply
Job Title : Technical Writing Specialist.Duration : 12 Months contract on W2.Work Schedule : Mon - Fri, Business Hours.PURPOSE AND SCOPE OF POSITION : . The Technical Writing Specialist supports the succ...Show moreLast updated: 30+ days ago
  • Promoted
Technical Writer

Technical Writer

Building Service 32BJ Benefit FundsNew York, NY, US
Full-time
Building Services 32BJ Benefit Funds.Funds”) is the umbrella organization responsible for administering Health, Pension, Retirement Savings, Training, and Legal Services benefits to over 100,...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Technical Writer

Regulatory Technical Writer

Aquestive Therapeutics Inc.Warren, NJ, US
Full-time
We are seeking a highly skilled Principal Regulatory Medical Writer to lead and contribute to key regulatory documentation efforts. The ideal candidate will have 4-8 years of experience in regulator...Show moreLast updated: 30+ days ago
  • Promoted
  • New!
Technical Writer

Technical Writer

TalentBurstNeshanic Station, NJ, United States
Temporary
Title : Technical Writer Med / Clin I.Duration : 12 months contract (High Chances of Extension).As a Technical Writer in the Operations Labeling Group, you will be responsible for creating, revising, a...Show moreLast updated: 4 hours ago
Technical Writer Job at Bristol Myers Squibb in New Brunswick

Technical Writer Job at Bristol Myers Squibb in New Brunswick

MediabistroNew Brunswick, NJ, United States
Full-time
Direct message the job poster from Bristol Myers Squibb.Duration : 12 Months with Possible Extension.Work Schedule : Mon-Friday (normal business hours). This individual will be responsible for deliver...Show moreLast updated: 4 days ago
  • Promoted
Technical Writer

Technical Writer

AmigoNew York, NY, US
Full-time
Amigo builds trust and safety infrastructure for AI in mission-critical environments.We partner with organizations in healthcare and other regulated sectors to deploy AI systems that operate reliab...Show moreLast updated: 12 days ago
Actalent is hiring : Technical Writer in Cranbury Township

Actalent is hiring : Technical Writer in Cranbury Township

MediabistroCranbury Township, NJ, United States
Full-time
Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.The role of Technical Writer involves developing, reviewing, and maintaining technical documents relat...Show moreLast updated: 4 days ago
Technical writer

Technical writer

Sunrise SystemsWarren, New Jersey, United States
Temporary
Quick Apply
Job Title : Technical Writing Specialist.Duration : 12 Months contract on W2.Work Schedule : Mon - Fri, Business Hours.Purpose and Scope of Position : . The Technical Writing Specialist supports the succ...Show moreLast updated: 30+ days ago
  • Promoted
Technical writing with labelling & Pharma

Technical writing with labelling & Pharma

Dawar Consulting, Inc.Somerville, NJ, US
Temporary
Our client, a world leader in diagnostics and life sciences, is looking for a.Long Term Contract (Possibility Of Further Extension). Company Benefits : Medical, Dental, Vision, Paid Sick leave, 401K....Show moreLast updated: 26 days ago
TalentBurst, an Inc 5000 company is hiring : Technical Writer in Branchburg Towns

TalentBurst, an Inc 5000 company is hiring : Technical Writer in Branchburg Towns

MediabistroBranchburg Township, NJ, United States
Temporary
Technical Writer Med / Clin I in the Operations Labeling Group.You will be responsible for creating, revising, and maintaining high-quality labeling documents for our medical products.Develop and mai...Show moreLast updated: 22 days ago
  • Promoted
Financial Technical Writer

Financial Technical Writer

RIT SolutionsNew York, NY, US
Full-time
Our client, a top-tier management consulting firm, has partnered with a leading Financial Services provider to hire a Financial Technical Writer. The ideal candidate will play a key role in deliveri...Show moreLast updated: 3 days ago