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Director, Regulatory and Medical Writing
4 months ago
About the role
Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Director, Regulatory and Medical Writing you will report to the VP, Head of Clinical Regulatory and Quality to support the Sana portfolio.
Cool stuff.
What you'll do
- Prepare and finalize clinical and/or regulatory documents such as, but not limited to, nonclinical and clinical study protocols, protocol amendments, Investigator's Brochures, regulatory briefing documents, health authority responses, IND summaries (i.e., Module 2), nonclinical and clinical study reports, charters, statistical analysis plans and pediatric documents
- Lead cross-functional document planning and review meetings. Interact with peer writers and cross-functional team members. Able to lead program-level or submission writing teams with supervision. Able to lead process working groups
- Coach or mentor cross-functional partners on document planning, processes, content, and provide peer review as needed
- Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and input from cross-functional team members, as needed
- Be the primary point of contact and champion for medical writing activities.
- Responsible for planning, setting strategy, and leading writing group for assigned program
- Maintain and apply knowledge of the industry, company, and regulatory guidelines
What we're looking for
- University/college degree required
- At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years of relevant medical and regulatory writing experience; experience with all stages of development is preferred
- Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types under general supervision, with input from cross-functional team members, as needed
- Strong attention to detail
- Strong oral and written communication skills
- Strong leadership skills, both in time management as well as in project/process management
- Able to resolve complex problems under general supervision
- Demonstrate learning agility
- Able to build solid and positive relationships with cross-functional team members
What you should know
- Masters or PhD preferred
- The base pay range for this position at commencement of employment is expected to be between $200,000 and $240,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience
How we work together for patients
- Lead from every seat - we seek to understand, act with honesty, and engage in the crucial conversations
- Thrive as a team - we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
- Make it happen - we value vigorous debate, alignment around our decisions, and resilient execution
Get to know us
At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.
Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off (various paid time off benefits, such as holidays, vacation, sick time, and parental leave), short- and long-term disability, employer paid basic life insurance, additional voluntary life insurance protection, financial wellness programs including financial planning resources, a 401(k) Plan with an immediately vested employer match, Tuition Reimbursement and Student Loan Repayment, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually. For more details on our benefits, visit Sana's Benefits Portal .
We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, social class (including caste/caste identity), taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.
To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.
