Job Description

Job Title: Senior Manager – Medical Writing

Company Overview:

Pulivarthi Group is a premier global provider of staffing and IT technology solutions, renowned for delivering exceptional services tailored to each client's unique needs. With a steadfast commitment to excellence, we merge expertise with innovation, ensuring cost-effective solutions of the highest quality. Our diverse client base spans healthcare, finance, government, and beyond, reflecting our adaptability and proficiency across industries. Operating in the United States, Canada, and Mexico, we pride ourselves on aligning with clients' cultures, deploying top-tier talent, and utilizing cutting-edge technologies. Pulivarthi Group stands as a beacon of reliability, efficiency, and innovation in the realm of staffing solutions.

Job Overview/Summary:

We are seeking an experienced Senior Manager – Medical Writing to lead the development of high-quality, scientifically accurate clinical and regulatory documents supporting global drug development programs. This role will serve as the primary medical writing contact for study teams, providing strategic oversight, managing timelines, mentoring junior writers, and coordinating deliverables to meet regulatory requirements.

Responsibilities:

• Serve as the primary medical writing contact on study teams, ensuring consistency, accuracy, and compliance with regulatory standards (ICH, GCP).

• Author, edit, and manage clinical and regulatory documents such as briefing packages, responses to regulatory agencies, and materials for agency/advisory committee meetings.

• Develop timelines, manage multiple projects, and coordinate efforts across cross-functional teams to produce high-quality deliverables.

• Lead or contribute to strategic regulatory documents including accelerated review applications, NDAs, and BLAs.

• Mentor and oversee junior writers; manage deliverables of contract or vendor writers as needed.

• Partner with CROs to ensure adherence to best practices, outsourcing strategies, and quality standards.

• Promote continuous improvement by influencing cross-functional practices to enhance quality, compliance, and efficiency.

• Maintain awareness of industry standards, regulatory requirements, and departmental SOPs.

Primary Skills:

• Expertise in medical writing for global clinical and regulatory submissions.

• Strong knowledge of ICH guidelines, GCP, and global regulatory standards.

• Demonstrated experience leading the preparation of NDA/BLA marketing applications.

• Excellent project management skills with the ability to manage multiple priorities and timelines.

• Exceptional verbal and written communication skills to collaborate across global teams.

Secondary Skills (Good to Have):

• Experience preparing and submitting major regulatory marketing applications.

• Familiarity with abbreviation managers/QC tools and authoring software such as MS Word, EndNote, and MS Project.

• Experience with non-clinical and clinical document authoring.

• Ability to evaluate and implement outsourcing strategies with CROs.

Qualifications:

• Bachelor’s degree in a relevant scientific/clinical/regulatory field (Advanced degree preferred).

• Minimum 7 years of medical writing experience, including experience as a lead writer for major regulatory submissions.

• Proven ability to manage multiple projects with competing priorities.

• Global regulatory submission experience strongly preferred.

• Strong organizational skills, attention to detail, and ability to work independently with minimal supervision.

Benefits/Perks:

• Competitive compensation package.

• Comprehensive health, dental, and vision insurance.

• Paid time off, holidays, and sick leave.

• Professional development and leadership training opportunities.

• Work in a global, collaborative environment with exposure to high-profile drug development projects.

Equal Opportunity Statement:

Pulivarthi Group is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive culture and celebrate authenticity. We do not discriminate on the basis of race, religion, color, national origin, gender, gender identity, sexual orientation, age, marital status, disability, protected veteran status, or any other legally protected characteristics.