Suna Solutions
Base Pay Range : $45.00/hr - $50.00/hr
Rate:
$45–$50/hour (W2)
Location:
Hybrid – Paramus, New Jersey, 07652
Schedule:
Monday to Friday, 8:00 AM – 5:00 PM
Contract Duration:
5 to 6 months
Position Overview We are seeking an experienced
CMC Writer / Project Manager
to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role blends technical writing expertise with project management capabilities to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.
Key Responsibilities
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
Manage timelines, deliverables, and stakeholder alignment for CMC workstreams.
Prepare and coordinate documentation for Annual Reports, DSURs, and responses to regulatory authority inquiries.
Ensure compliance with FDA, EMA, and ICH guidelines, as well as internal quality standards.
Collaborate with cross-functional teams to gather accurate technical and scientific information.
Identify potential regulatory risks and propose mitigation strategies.
Contribute to process improvements for CMC documentation and submission workflows.
Qualifications
Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, or related discipline.
Minimum 5 years of experience in pharmaceutical regulatory writing or CMC project management.
Strong understanding of manufacturing processes, analytical methods, specifications, and validation activities.
Familiarity with global regulatory frameworks and eCTD submissions.
Excellent technical writing, communication, and organizational skills.
Proficiency with Microsoft Office (Word, Excel, Outlook 365, PowerPoint); experience with Veeva Vault or Smartsheet is a plus.
Preferred Skills
Hands‑on experience supporting IND, NDA, BLA, EU MAA, or IMPD submissions.
Ability to interpret and apply regulatory guidelines in a practical and compliant manner.
Strong project management abilities and confident stakeholder communication.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMMODATION Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.
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Rate:
$45–$50/hour (W2)
Location:
Hybrid – Paramus, New Jersey, 07652
Schedule:
Monday to Friday, 8:00 AM – 5:00 PM
Contract Duration:
5 to 6 months
Position Overview We are seeking an experienced
CMC Writer / Project Manager
to support regulatory submissions and ensure timely, high-quality documentation for global health authorities. This role blends technical writing expertise with project management capabilities to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.
Key Responsibilities
Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
Manage timelines, deliverables, and stakeholder alignment for CMC workstreams.
Prepare and coordinate documentation for Annual Reports, DSURs, and responses to regulatory authority inquiries.
Ensure compliance with FDA, EMA, and ICH guidelines, as well as internal quality standards.
Collaborate with cross-functional teams to gather accurate technical and scientific information.
Identify potential regulatory risks and propose mitigation strategies.
Contribute to process improvements for CMC documentation and submission workflows.
Qualifications
Bachelor’s degree or higher in Chemistry, Pharmaceutical Sciences, or related discipline.
Minimum 5 years of experience in pharmaceutical regulatory writing or CMC project management.
Strong understanding of manufacturing processes, analytical methods, specifications, and validation activities.
Familiarity with global regulatory frameworks and eCTD submissions.
Excellent technical writing, communication, and organizational skills.
Proficiency with Microsoft Office (Word, Excel, Outlook 365, PowerPoint); experience with Veeva Vault or Smartsheet is a plus.
Preferred Skills
Hands‑on experience supporting IND, NDA, BLA, EU MAA, or IMPD submissions.
Ability to interpret and apply regulatory guidelines in a practical and compliant manner.
Strong project management abilities and confident stakeholder communication.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT Suna Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
Applicants, with criminal histories, are considered in a manner that is consistent with local, state, and federal laws.
REQUESTING AN ACCOMMODATION Suna Solutions is committed to providing equal employment opportunities for persons with disabilities or religious observances, including reasonable accommodation when needed. If you are hired by Suna Solutions and require accommodation to perform the essential functions of your role, you will be asked to participate in our reasonable accommodation process. Accommodations made to facilitate the recruiting process are not a guarantee of future or continued accommodations once hired.
If you would like to be considered for employment opportunities with Suna Solutions and have accommodation needs for a disability or religious observance, please call us at 1 (888) 223-4788, send us an email or speak with your recruiter.
PAY TRANSPARENCY POLICY STATEMENT Compensation for roles at Suna Solutions varies depending on a wide array of factors including but not limited to the specific client, office or remote location, role, skill set and level of experience. As required by local law, Suna Solutions provides a reasonable pay scale to include the hourly or salary range that Suna Solutions reasonably expects to pay for roles that may be hired in California, Colorado, New York City or Washington.
#J-18808-Ljbffr