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Joel Kelley
Director, Medical Writing
Summary
Seeking a highly skilled and experienced Director of Medical Writing to lead and manage the medical writing department. The ideal candidate will have a proven track record of successfully developing and executing global medical writing strategies across multiple therapeutic areas. Responsibilities include overseeing the production of high-quality medical content, establishing and maintaining relationships with key stakeholders, developing and implementing quality assurance processes, managing a budget, collaborating with cross-functional teams, and providing strategic guidance and mentorship to medical writers. Qualifications include a Ph.D. or Master’s degree in biomedical sciences, and strong experience in medical writing, clinical trial protocol development, regulatory document preparation, and medical device regulatory affairs.
Education
Ph.D. or Master’s Degree in biomedical sciences, such as medicine, biology, or pharmacy
September 2018
Skills
- Medical Writing
- Clinical Trial Protocol Development
- Regulatory Document Preparation
- Medical Device Regulatory Affairs
- Scientific Writing
- Technical Writing
Work Experience
Director, Medical Writing
- Managed a budget of $X and successfully reduced operational costs by Y%.
- Collaborated with crossfunctional teams to ensure the alignment of medical writing with overall product development goals.
- Provided strategic guidance and mentorship to medical writers, fostering their professional growth and development.
- Developed and delivered training programs on medical writing best practices and regulatory requirements.
Director, Medical Writing
- Led a team of medical writers in developing and executing global medical writing strategies across multiple therapeutic areas.
- Oversaw the production of highquality medical content, including clinical study reports, regulatory submissions, and patient education materials.
- Established and maintained relationships with key stakeholders, including clinical investigators, regulatory agencies, and industry partners.
- Developed and implemented quality assurance processes to ensure the accuracy and compliance of all medical writing deliverables.
Accomplishments
- Led a team of medical writers in developing clinical trial protocols and regulatory submissions, resulting in accelerated drug approvals
- Established and implemented best practices for medical writing, ensuring compliance with industry regulations and ethical guidelines
- Oversaw the development and execution of medical writing training programs, enhancing the skills and knowledge of medical writing professionals
- Collaborated with crossfunctional teams to translate complex scientific data into compelling and accurate medical content
- Developed innovative medical writing strategies, improving the efficiency and effectiveness of regulatory submissions
Awards
- Recipient of the Medical Writing Excellence Award for outstanding contributions to the industry
- Recognized with the Industry Leader Award for exceptional leadership in medical writing
- Awarded the Best Medical Publication Award for groundbreaking research and scientific writing
Certificates
- Certified Medical Writer (CMW)
- Board Certified Medical Editor (BCME)
- Regulatory Affairs Certification (RAC)
- Certified Clinical Research Coordinator (CCRC)
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How To Write Resume For Director, Medical Writing
- Highlight your experience in leading and managing a team of medical writers.
- Showcase your expertise in developing and executing global medical writing strategies across multiple therapeutic areas.
- Quantify your accomplishments whenever possible, such as the number of clinical study reports or regulatory submissions you have overseen.
- Demonstrate your strong relationships with key stakeholders, including clinical investigators, regulatory agencies, and industry partners.
- Emphasize your ability to develop and implement quality assurance processes to ensure the accuracy and compliance of all medical writing deliverables.
Essential Experience Highlights for a Strong Director, Medical Writing Resume
- Lead and manage a team of medical writers in developing and executing global medical writing strategies across multiple therapeutic areas.
- Oversee the production of high-quality medical content, including clinical study reports, regulatory submissions, and patient education materials.
- Establish and maintain relationships with key stakeholders, including clinical investigators, regulatory agencies, and industry partners.
- Develop and implement quality assurance processes to ensure the accuracy and compliance of all medical writing deliverables.
- Manage a budget of $X and successfully reduce operational costs by Y%.
- Collaborate with cross-functional teams to ensure the alignment of medical writing with overall product development goals.
- Provide strategic guidance and mentorship to medical writers, fostering their professional growth and development.
Frequently Asked Questions (FAQ’s) For Director, Medical Writing
What are the key responsibilities of a Director of Medical Writing?
The key responsibilities of a Director of Medical Writing include leading and managing a team of medical writers, overseeing the production of high-quality medical content, establishing and maintaining relationships with key stakeholders, developing and implementing quality assurance processes, managing a budget, and collaborating with cross-functional teams.
What are the qualifications for a Director of Medical Writing?
The qualifications for a Director of Medical Writing typically include a Ph.D. or Master’s degree in biomedical sciences, and strong experience in medical writing, clinical trial protocol development, regulatory document preparation, and medical device regulatory affairs.
What are the key skills for a Director of Medical Writing?
The key skills for a Director of Medical Writing include strong leadership and management skills, excellent communication and interpersonal skills, and a deep understanding of medical writing principles and regulatory requirements.
What is the career path for a Director of Medical Writing?
The career path for a Director of Medical Writing typically begins with a role as a Medical Writer. With experience, Medical Writers can progress to roles such as Senior Medical Writer, Associate Director of Medical Writing, and eventually Director of Medical Writing.
What are the salary expectations for a Director of Medical Writing?
The salary expectations for a Director of Medical Writing can vary depending on experience, location, and company size. According to Glassdoor, the average salary for a Director of Medical Writing in the United States is $120,000 per year.
What are the benefits of working as a Director of Medical Writing?
The benefits of working as a Director of Medical Writing include a competitive salary, a challenging and rewarding career, and the opportunity to make a significant impact on the development of new medical treatments and therapies.