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

cDZ4SFNmS1h4dE5Bc3UzcjU3b0xKTUVaTlE9PQ==
  • SimulStat Inc.
  • Summit, NJ

Job Description

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.

Job Tags

Local area,

Similar Jobs

JLC Builders

Sonic Crew Member Job at JLC Builders

 ...great service, its great experiences. We are looking for full-time/part-time energetic, friendly and team-oriented employees....  ...area clean and stocked. Requirements: Must be at least 16 years or older. Must have reliable transportation to and from work... 

Aveanna Healthcare

Home Care Nurse (LPN) Job at Aveanna Healthcare

 ...Licensed Practical / Vocational Nurse LPN/LVN We are one of the largest private duty...  ...ranked by Comparably Why Join Us?~ Health, Dental, Vision and Company-Paid Life Insurance...  ...~ Aveanna has a tablet in each patients home allowing for electronic documentation ~... 

GreatAuPair LLC

Personal Assistant Job at GreatAuPair LLC

Extensive household maintenance like cleaning all rooms, doing laundry, and managing waste, along with domestic tasks such as cooking meals, running errands, and grocery shopping

Iowa Department of Administrative Services

Tax Compliance Internship Job at Iowa Department of Administrative Services

 ...Apply ? Tax Compliance Internship Salary $18.25 Hourly Location State of Iowa - Remote, IA Job Type...  ...Bureau, Operations Bureau, and Collections Bureau Hours: Part-time during semester approximately 12-16 hours per week. Full-time during... 

Sweet Carolina Travels

Lifestyle Experience Specialist Job at Sweet Carolina Travels

 ...experiences. Research and develop unique experiences spanning travel, wellness, entertainment, dining, and cultural activities....  ...experience in hospitality, travel planning, event management, or luxury services preferred. Ability to work independently and manage...