Associate Director, Medical Writing (EDG-2025072)
Edgewise Therapeutics
On-site
United States
$160,000 - $190,000 USD yearly
Medical and Scientific Writing, Editing, Media & Communications
Associate Director, Medical Writing
About Edgewise Therapeutics:
At Edgewise, we are on a mission to discover new medicines that improve the lives of patients facing serious muscle disease. Our intimate knowledge of muscle biology and biophysics along with our ability to identify and design muscle specific precision small molecules have enabled us to rapidly advance our skeletal muscle and cardiac muscle product candidates into the clinic while also building a robust pre-clinical pipeline. With this focus on therapeutics designed to protect and improve muscle health, our goal is to dramatically enhance the lives of people living with progressive muscle disorders.
We have assembled an experienced and highly motivated leadership team with a strong track record in the biotechnology and pharmaceutical industry to build the leading, global muscle disease biopharmaceutical company. Come join us make a significant difference in the lives of patients!
About the Position:
The Associate Director, Medical Writing will be responsible for authoring, editing, formatting, QC review, and/or assisting with the writing of clinical and regulatory documents, including, but not limited to, clinical study protocols, Investigator’s Brochures, clinical study reports, and IND/NDA components. The Associate Director, Medical Writing will provide medical writing support across Edgewise Therapeutics clinical development programs.
Essential Job Duties and Functions:
- Serve as the medical writing lead for assigned programs/studies to plan, write, edit, and review clinical and regulatory documents;
- Provide input and accountability for development of medical writing timelines and project management of all medical writing deliverables in collaboration with cross-functional team members and vendors on assigned programs/studies;
- Manage large and complex medical writing projects which may include the supervision of other medical writers and QC reviewers to ensure delivery of documents according to project timelines and to acceptable quality standards;
- Coordinate and/or perform QC review as needed to ensure document accuracy and consistency with company standards;
- Follow Edgewise Therapeutics medical writing standards, policies, SOPs, and other written instructions as needed to ensure that delivered documents are of the highest quality;
- Serve as the Subject Matter Expert for assigned clinical teams regarding Edgewise Therapeutics medical writing standards and practices, style guides, document templates, etc.;
- Generate document templates and other materials and assist with SOP development to support medical writing activities, as needed;
- Demonstrate effective leadership and working skill in teamwork, delegation, organization and coordination;
- Work independently to manage and prioritize workload to ensure deliverables are completed per time and quality goals;
- Provide training, supervision, and/or support to other medical writers as needed to ensure delivery of documents according to project timelines and to acceptable quality standards;
- Provide additional support related to the position as required by direct supervisor.
- Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
- Perform other duties as assigned by supervisor.
Required Education, Experience and Skills:
What basic qualifications do we require?
- Education: BS/BA at minimum with MS/PhD in a life sciences discipline preferred;
- Must have at least 5 years of experience in Biotech and/or Pharmaceutical industries, or equivalent;
- Management roles/experience within Medical Writing, with effective people management, and interpersonal, communication;
- Extensive medical writing knowledge, including prior IND/NDA/MAA submission experience;
- Subject-matter expert regarding FDA/ICH guidelines and GCP;
- Strong written and verbal communication skills;
- Expert ability in Microsoft Word, Excel, and PowerPoint;
- Team player, capable of adapting to changing demands and aggressive timelines;
What additional qualifications are we seeking?
- Ability to self-motivate and lead with confidence is critical
- Excellent organizational and time management skills, sense of urgency
- Excellent attention to detail with strong analytical and problem-solving skills
- Project Management skills
Salary range: $160,000 - $190,000, title and salary commensurate with experience
Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan.
There is no deadline because the employer accepts applications on an ongoing basis.