Medical Writer

Highly Competitive
  1. Permanent
  2. Publishing & Submissions
  3. United States
Maryland, USA
Posting date: 12 Jul 2024
61351

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Medical Writer - Permanent - Fully remote within Maryland

Proclinical is seeking a Medical Writer with expertise in FDA regulated product development.

Primary Responsibilities:

This role is ideal for someone who thrives in a dynamic environment, can effectively manage multiple tasks, and is committed to delivering high-quality work within set timelines. The successful candidate will have the opportunity to contribute to regulatory submissions, engage in innovative thinking, and actively participate in the publication of articles.

Skills & Requirements:

  • Writing and reviewing regulatory submissions such as Pre-INDs, INDs, CTDs, ODDs (FDA and EMA), and white papers.
  • Contributing to scientific and innovative thinking.
  • Managing deadlines and multitasking effectively.
  • Engaging actively in the publishing of articles.
  • Performing literature reviews.
  • Communicating directly with clients under the direction of the project leader.
  • Participating in business development and expansion of existing business.
  • Assisting in the training and development of junior staff.

The Medical Writer's responsibilities will be:

  • PhD in a life science or related field of study.
  • Expertise in FDA regulated product development.
  • Proven working history in writing and reviewing regulatory submissions.
  • Excellent communication skills, both written and oral.
  • Ability to work well in a team environment.
  • Experience with CMC writing (FDA and EMA) is preferred.
  • Proven ability to manage deadlines and multitask effectively.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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