Technical writer

Innova Solutions has a client that is immediately hiring for a Regulatory- Technical writer

Position type : Full-time- Contract

Duration : 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 :

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

314-230-0976

Mohit.Vyas@innovasolutions.com

PAY RANGE AND BENEFITS :

Pay Range

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).

ABOUT INNOVA SOLUTIONS : Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions :

Website : https : / / www.innovasolutions.com /

Innova Solutions offers a referral bonus for qualified Ambassadors who refer eligible referrals. Submit referrals at https : / / innovasolutions.workllama.com / atsuser / anonreferafriend  and earn $250-$1,000 per referral.

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.  If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed.  Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities.   Innova Solutions (HireGenics / Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.

The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.