Position: Sr. Medical/Regulatory Writer
Location: Florham Park, NJ – on site. Must work office based in Florham Park, NJ after COVID restrictions are lifted. Strong remote candidates outside of commuting distance will be considered
Contract to perm (6 month contract with potential to extend or convert to perm)
Medical/Dental benefits available
The Senior Medical Writer will be responsible for managing the development of clinical and regulatory documents (eg, protocols, clinical study reports, investigator’s brochures), as well as medical communications (eg, abstracts, posters, manuscripts). This individual will work collaboratively with team leaders across multiple functional areas to drive and manage the processes leading to production of high quality documents in a timely manner.
- Prepares Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product development
- Leads the development of clinical and regulatory documents (eg, clinical protocols, clinical study reports, investigator brochures, clinical summaries)
- Leads the development of abstracts, slides/ posters, and primary manuscripts presenting clinical study data
- Participates in strategic publication planning and implementation of publication plans
- Provides project teams with expertise and strategic guidance on analysis and presentation of efficacy and safety data in documents
- Organizes, conducts, and leads cross-functional document development meetings
- Develops strategy for document preparation and manages the overall document development process, including timelines, document reviews, and approvals in adherence with company standard operating procedures and regulatory guidance
- Works with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs
- Contributes to program strategy, through collaborative engagement with personnel across different functional areas and departments
- Leads or participates in development of medical writing processes and infrastructure development
- Contributes to clinical trial registry postings and results disclosures on US and EU platforms
- May coordinate the activity or serve as internal contact for contract medical writers and other third-party vendors
· Develops and implements templates, company styles, and standard operating procedures to ensure consistent, high quality deliverables
Education, Qualities, or Experience Required
The ideal candidate will possess the following attributes:
· Minimum BA/BS plus 8 years experience in pharmaceutical/biotechnology industry (5 years for PhD/PharmD level), with at least 5 years as medical writer (3 years for PhD/PharmD).
· Prior NDA/BLA/MAA submission experience preferred
· Works well and efficiently in fast-paced environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles.
· Positive, flexible, open-minded attitude; thrives in collaborative environment
· Comfortable leading teams and educating team members as needed during process of document development
· Organized, results-oriented, deadline-driven. Experience managing multiple projects
· Skilled in written and oral communications. Meticulous attention to detail.
· Comfortable taking the initiative, solving problems at hand, and escalating issues as needed
· Advanced analytical ability and expertise at data interpretation and presentation
· Expertise with software and templates commonly used in regulatory medical writing (ie, MS-Word, Excel, Powerpoint, Adobe Acrobat). Experience with MS-Project preferred.
Joulé Clinical StaffingJoule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.