Innova Solutions has a client that is immediately hiring for a
Regulatory- Technical writer.Position type: Full-time- ContractDuration: 12 Months Location: New Brunswick, NJ (50% onsite)As a
Regulatory- Technical writer you will:
- Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses the 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 CTD 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.
The ideal candidate will have:- 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; 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 biotech/pharma e2e product development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Qualified candidates should
APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines.
ASK ME HOW.Thank you!
Mohit Vyas
Mohit.Vyas@innovasolutions.com
PAY RANGE AND BENEFITS:Pay Range*: $43 - $45 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
Qualified candidates should
APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines.
ASK ME HOW.Thank you!
Mohit Vyas
Mohit.Vyas@innovasolutions.com
