Associate Medical Writer

2 weeks ago

Wilmington, United States Deeply Rooted Psychological Services LLC Full time

*Job Overview:* Are

ou a post
- toral fellow who is passionate abou

providing cultur
- y-sens

tive and
- ength-based ment

ealth services to divers
- eply Rooted Psychological Services LLC *About Us:* Deeply Rooted Psychology is an innovative therapy practice

hat provid
- compassionate and c

turally-sensitive me
- l health services to diverse populations in Wilmington, Delawar

We specialize in supporting young adults and those i

life transitions with anxiety, depression, trauma, and other common struggles. We are looking for a therapist who can join our team of professionals and contribute to the growth of our company. We are looking for a postdoctoral fellow who can join our team and grow with our innovative company. *Responsibilities:*
- Authors complex clinical regulatory documents (e.g., clinical study protocols, clinical study reports and documents to support meetings with regulatory agencies) in partnership with key stakeholders
- Serves as the lead Medical Writing for complex or pivotal clinical studies for multiple programs or therapeutic areas
- Provides expert review of study-level and program-level documents
- Participates in developing key messages for complex clinical regulatory documents
- Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
- Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
- Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents
- Ensures document preparation is compliant with company and industry standards
- Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies Knowledge and Skills:

- Outstanding written and oral communication skills
- Extensive experience writing and editing clinical regulatory documents
- Ability to analyze, interpret, and summarize highly complex data
- Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
- Ability to mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions
- Highly developed project management and organizational skills
- Ability to manage challenging, high-value projects
- Initiative and creativity in solving complex problems; ability to have a substantial role in developing and implementing improvements in cross-functional processes
- Serves as the lead Medical Writing for complex or pivotal clinical studies for multiple programs or therapeutic areas
- Provides expert review of study-level and program-level documents
- Participates in developing key messages for complex clinical regulatory documents
- Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
- Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
- Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents
- Ensures document preparation is compliant with company and industry standards
- Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies *Qualifications:*
- Master’'s degree is required.
- Minimum of 2+ years related experience is preferred.
- 3+ years in a Medical Education role is favorable.
- Proficient with Microsoft Office, including Outlook, Word, Excel and PowerPoint.
- Excellent verbal and written communication skills, with a demonstrated ability to communicate clearly and professionally.
- Provides expert review of study-level and program-level documents
- Participates in developing key messages for complex clinical regulatory documents
- Provides leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
- Provides strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
- Contributes to content and strategy of presentations for regulatory agency advisory committee meetings; may prepare advisory committee briefing documents
- Ensures document preparation is compliant with company and industry standards
- Strong contributor on cross-functional teams working on standard operating procedures, process improvements, and integration of new tools and technologies Benefits:

- Competitive pay and bonuses. Will receive regular clinical supervision.
- Flexible schedule, with weekday, evening, and weekend hours available.
- Ideal for early career psychologists seeking support and guidance in a private practice se

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