Director, Regulatory and Medical Writing
2 weeks 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 guidelinesWhat 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 membersWhat 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 experienceHow 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 executionGet 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.
-
Director, Regulatory and Medical Writing
2 weeks ago
Cambridge, Massachusetts, United States Sana Biotechnology Full timeAbout 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...
-
Director, Regulatory and Medical Writing
2 weeks ago
Cambridge, United States BioSpace Full timeJob DetailsAbout 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...
-
Director, Medical Writing
3 days ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
-
Director, Medical Writing
2 days ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
-
Associate Director, Medical Writing
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Associate Director of Medical Writing is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of Medical Writing. The chosen candidate will not just be a part of Modernas medical writing team but will lead the charge in delivering high-quality clinical and regulatory writing. From masterminding the...
-
Associate Director, Medical Writing
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Associate Director of Medical Writing is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of Medical Writing. The chosen candidate will not just be a part of Modernas medical writing team but will lead the charge in delivering high-quality clinical and regulatory writing. From masterminding the...
-
Associate Director, Medical Writing
6 days ago
Cambridge, United States Moderna, Inc. Full timeThe Role:The Associate Director of Medical Writing is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of Medical Writing. The chosen candidate will not just be a part of Modernas medical writing team but will lead the charge in delivering high-quality clinical and regulatory writing. From masterminding the...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical and regulatory writing. From meticulous planning and coordination to delivering the final drafts, the role demands a keen eye for detail and a robust...
-
Sr. Manager, Medical Writing
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Senior Manager of Medical Writing is a high-impact role, reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from the meticulous planning and coordination...
-
Senior Manager, Medical Writing
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Senior Manager of Medical Writing is a high-impact role, reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from the meticulous planning and coordination...
-
Sr. Manager, Medical Writing
6 days ago
Cambridge, United States Moderna, Inc. Full timeThe Role:The Senior Manager of Medical Writing is a high-impact role, reporting directly to the Associate Director, Director of Medical Writing, or Senior Director of Medical Writing. The chosen individual will not just be responsible for, but will excel in delivering high-quality clinical and regulatory writing, from the meticulous planning and coordination...
-
Sr. Manager, Medical Writing
6 days ago
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in both traditional medical writing and technological innovation. Reporting directly to the Senior Director of Medical Writing Delivery & Excellence, the chosen individual will not only be responsible for delivering...
-
Director, Regulatory Genomics
7 days ago
Cambridge, Massachusetts, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Director, Regulatory Genomics
5 days ago
Cambridge, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Director, Regulatory CMC
4 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Director, Regulatory CMC
1 month ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Director, Regulatory CMC
1 month ago
Cambridge, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Sr. Manager, Medical Writing
6 days ago
Cambridge, United States Moderna, Inc. Full timeThe Role:The Senior Manager of Medical Writing Delivery & Excellence is a high-impact role that demands a dynamic blend of expertise in both traditional medical writing and technological innovation. Reporting directly to the Senior Director of Medical Writing Delivery & Excellence, the chosen individual will not only be responsible for delivering...
-
Cambridge, Massachusetts, United States Moderna, Inc. Full timeThe Role:Moderna Therapeutics is seeking an Assoc. Director of Regulatory Labeling to support current and existing programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward-looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for products...
-
Cambridge, United States Moderna, Inc. Full timeThe Role:Moderna Therapeutics is seeking an Assoc. Director of Regulatory Labeling to support current and existing programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward-looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for products...