Sr. Medical Writer- REMOTE
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.
Recommended Jobs
Refugee Case Worker/Case Worker Assistant
The Immigrant & Refugee Services Division at Catholic Charities of the Archdiocese of Newark seeks a Case Worker/Case Worker Assistant to provide case management services to Refugee Program clients…
Sales Representative (Remote and No Experience Needed)
PLEASE NO INTERNATIONAL CANDIDATES AT THIS TIME. WE WILL NOT SPONSOR VISA (H1-2-2b) Stratford Davis Staffing is proud to bring this opportunity to the Sales community. From Our Partner: Our c…
LCSW/LPC
Want to join an awesome team of clinicians? Do you prefer to focus on the clinical work as a therapist and not be bothered with billing, marketing, and other admin responsibilities? Are you looking f…
Client Advisor
Bottega Veneta seeks a Client Advisor in Short Hills to drive sales and enhance client relationships. The role involves achieving sales targets, utilizing advanced selling techniques, and maintaining …
Princeton Costco Sales Rep - $23-$25/hr + COMMISSION!
WE ARE CURRENTLY HIRING FOR THE PRINCETON LOCATION! Seeking positive, energetic, and sales-focused professionals who can be passionate brand ambassadors! This is a fantastic opportunity selling nu…
Account Coordinator, Buying Services
Description Position at Compas The Account Coordinator role is a dynamic entry-level position in the healthcare media buying industry. The Account Coordinator will be responsible for executing me…
Sr System programmer
As a Senior System Programmer at Tek Spikes, you will be responsible for developing and optimizing system-level software solutions, ensuring high performance and reliability across our platforms. In …
Health & Wellness Coach - Temporary
Job Description Job Title: Onsite Wellness Coach, 32 hours a week TEMPORARY starting IMMEDIATELY Camden County and Langhorne, PA Job Purpose: The wellness coach provides onsite, comprehen…
Shipping Clerk I PM Shift
The position is responsible to ensure packages are shipped on time and in accordance with sales order instructions so customers will receive products in the same condition that products were sent. Wo…
OTC Derivatives Operations Analyst
At Bank of America, we are guided by a common purpose to help make financial lives better through the power of every connection. We do this by driving Responsible Growth and delivering for our …