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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