Job Description

REMOTE MEDICAL WRITER – CLINICAL TRIAL REPORTS needed for a LONG-TERM CONTRACT opportunity with Yoh’s client.

THE BIG PICTURE – TOP SKILLS YOU SHOULD POSSESS:

• Medical writing
• Clinical trial submission/reports
• Pharmaceutical industry experience
• Project management

WHAT YOU’LL BE DOING:

• 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 coordinates 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 guidance and regulations governing regulatory documents and submissions to global health authorities.

WHAT YOU NEED TO BRING TO THE TABLE: 

• Advanced degree (eg, MS, PhD) or other related qualifications (eg, Pharm D, BSN) are desirable.
• Minimum of 6-8 years of experience in medical writing, preferably in the pharmaceutical industry.
• 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. This experience is necessary to provide the depth and breadth of understanding of drug development issues.
• Evidence of the skills necessary to manage submissions.

WHAT’S IN IT FOR YOU?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs

OPPORTUNITY IS CALLING, APPLY NOW FOR THE REMOTE MEDICAL WRITER – CLINICAL TRIAL REPORTS.

RECRUITER:  Vera Evan

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

#Zip-SA

#IND-SA

#Mon-SA

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

Company Description

Investment Management Company