Sr. Medical Writer- REMOTE at SimulStat Inc. Summit, NJ

SimulStat Inc.; Summit (NJ); Remote; USD 110,000 - 150,000; Full time

Job summary

SimulStat Inc. seeks a Sr. Medical Writer to support the development of global regulatory documentation strategy and the execution of tactics.

You will conceptualize and develop medical communications for reviewer-friendly clinical documents to support regulatory agency review, coordinating progress against global regulatory plans. The role requires a strong background in medical writing, regulatory submissions, and project management, with 6–8 years of industry experience and advanced degrees

Qualifications

• Minimum 6–8 years of medical writing experience.
• Experience managing regulatory submissions desirable.
• Knowledge of drug development and regulatory requirements.

Responsibilities

• Develop and contribute to global regulatory documentation strategy and execution.
• Coordinate writing and reviews of regulatory submission documents.
• Adhere to SOPs and guidelines governing regulatory documents and submissions to health authorities.
• Establish target dates and communicate timelines to management.

Skills

Medical writing

Regulatory knowledge

Project management

Analytical skills

Team collaboration

Regulatory submissions

Computer skills

Education

Bachelor's degree in life sciences

MS/PhD desirable

Tools

MS Office

Job description

Sr. Medical Writer - REMOTE job at SimulStat Inc.. Summit, NJ. Contributes to development of global regulatory documentation strategy and execution of tactics. Conceptualizes and develops medical communications for message‑driven, concise reviewer‑friendly clinical documents in order to support regulatory agency review. Coordinates medical writing/regulatory submission progress against global regulatory strategic communication plans. Writes or co‑ordinates writing and reviews of clinical trial reports, narratives, clinical trial protocols, local working instructions, submission documents (ISS, ISE, CO, RMP), investigator brochures, annual IND updates, and other documents as needed. Reviews DPP and SAP as needed. Estimates resources needed and communicates with Director of Medical Writing. Establishes target dates for completion of assignments. Communicates with management when timelines are threatened. Establishes and enforces quality standards for documents. Adherence to Company SOPs, Best Practices, Working Instructions, as well as the accepted industry guidelines and regulations governing regulatory documents and submissions to global health authorities.

Skills

The incumbent must have relevant medical/scientific knowledge, project management skills, analytical skills, knowledge of drug development and regulatory requirements, excellent written communication skills, computer skills, and ability to work as part of a team. The above are necessary to provide the depth and breadth of understanding of drug development issues.

Education

College degree plus a minimum of 6‑8 years experience in medical writing, preferably in the pharmaceutical industry. Evidence of the skills necessary to manage submissions. Evidence of depth of knowledge in multiple therapeutic areas desirable. Advanced degree (eg, MS, PhD) or other related qualifications (eg, Pharm D, BSN) are desirable.