Associate Director Medical Writing
Associate Director Medical Writing
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 175000 - 190000
1 Vacancy
Job Description
THIS POSITION WILL BE ONSITE IN ONE OF THE FOLLOWING LOCATIONS: San Francisco Bay Area / Miami FL /Princeton New Jersey
*Relocation support will be considered for this role
Overview of Role:
The Associate Director Medical Writing will collaborate with colleagues to produce highquality strategically aligned documents supporting the regulatory requirements of a clinical development program ensuring completeness accuracy and compliance with US and exUS regulatory requirements.
Role and Responsibilities:
- Prepare & edit clinical/regulatory documents including protocols/protocol amendments clinical study reports (CSRs) Investigators Brochures briefing documents Module 2 clinical summary documents and other regulatory submissions as needed
- Interact with document authors contributors and reviewers (including members of Biometrics Clinical Operations Clinical Development Drug Safety and Regulatory Affairs) to acquire necessary input into documents
- Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
- Manage medical writing timelines for assigned documents to ensure ontime deliverables that meet business needs
- Facilitate comment resolution and adjudication with authors reviewers and project teams
- Participate in the development/refinement of medical writing processes SOPs work instructions templates and style and content guides to ensure efficient preparation of high quality medical writing deliverables
Experience Education and Specialized Knowledge and Skills:
- BA/BS degree in a scientific field required; advanced scientific degree (PhD PharmD or MS) preferred
- 8 years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them) including experience writing clinical study protocols clinical study reports investigators brochures clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higherlevel summary documents.
- Knowledge of oncology disease areas preferred
- Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guideline
- Ability to write and edit complex material to ensure accuracy clarity consistency and effectiveness
- Excellent attention to detail multitasking prioritization and flexibility
- Excellent communication skills with proven ability to interact in a crossfunctional environment
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
- Proficiency in use of MS Office applications Adobe Acrobat electronic document management systems and templates.
- Comfortable in a fastpaced small company environment with minimal direction and able to adjust workload based on changing priorities
- Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal direction
- Ability to think strategically be resourceful and lead with minimal direction
The pay range for this role is $175000$190000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.
Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.
Required Experience:
Director
Employment Type
Full-Time
