1,593 Regulatory Writing jobs in the United States

SUMMARY/JOB PURPOSE :

Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross-functional documents and reports as needed.

DUTIES/RESPONSIBILITIES:

• Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience.

• Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.

• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in-text tables.

• Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.

• Proposes and manages timelines for the document development process from initiation through approval.

• Oversees the assembly of appendices for regulatory submission documents as needed.

• Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.

• Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.

• Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.

• Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.

• Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

• No direct reports.

• Supervises work of junior writers and regulatory editors on document tasks.

• May direct and review the work of contract writers as needed.

• Mentors less experienced writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of thirteen years of related experience including industry; or,

• MS/MA degree in related discipline and a minimum of eleven years of related experience including industry; or,

• PhD in related discipline and a minimum of eight years of related experience including industry; or,

• Equivalent combination of education and experience.

• Active AMWA member with certificate or certification preferred; BELS certification a plus.

Experience:

• Experience in Biotech/Pharmaceutical industry is required.

• A minimum of seven years of regulatory/medical/technical writing or equivalent writing experience in the pharmaceutical industry, including experience supervising less experienced writers.

• Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).

• Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications.

• Familiarity with the therapeutic area of oncology is essential.

• Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidelines, and GCP standards.

• Advanced knowledge of AMA style, medical terminology, and clinical data analysis.

• Professional certification (e.g., AMWA, BELS) is beneficial.

Knowledge, Skills and Abilities:

• Develops and manages plans, establishes timelines, and sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high-quality work.

• Applies extensive knowledge of the regulatory framework, industry drivers, and practices to develop innovative approaches and manage complex work.

• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.

• Strong interpersonal skills and ability to accommodate differing views to influence an agreed-upon resolution.

• Facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.

• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing, and applying key information to solve problems. Provides regulatory writing expertise to cross-functional teams. Understands the longer-term consequences of decisions and actions.

• Acts with integrity to build trust and execute on team objectives that contribute to departmental goals.

• Capable of proactively assessing workload, trends, tasks, and priorities for the area of responsibility.

• Plans and executes multiple activities.

• Considers alternative methods and contingency plans to avoid potential issues.

• Designs and implements solutions to address project-level challenges, taking into consideration the broader impact.

• Environment: primarily working indoors.

#LI-MB1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Associate Director/Director, Medical & Regulatory Writing Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Essential Job Functions Prepares, edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical summary experience a plus. Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. Works closely with the study team to reach consensus on timelines for deliverables. Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments. Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs. Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency. May assist in providing oversight of vendors including contract writers, QC reviewers, and document formatters. Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents. Maintain current knowledge of industry trends and best practices for regulatory and scientific writing. Performs other duties as assigned Job Requirements Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required. PhD degree is preferred. Must have a minimum of 7+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred. Must have experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus. Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view. Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission. Ability to manage competing priorities in a fast-paced environment. Excellent problem solving, organizational, and analytical critical thinking skills. Excellent written and verbal communication skills. Strong attention to detail related to consistency, grammar, syntax, and formatting. Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus. Proficient in MS Office Suite, EndNote, and Adobe Acrobat. Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva. Ability to travel up to approximately 10% of the time. The base range for an Associate Director is $175,183 - $04,532 per year and for a Director it is 215,889 - 241,291. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus. #LI-RM1 Kura’s Values that are used for candidate selection and performance assessments: We work as one for patients We are goal-focused and deliver with excellence We are science-driven courageous innovators We strive to bring out the best in each other and ourselves The Kura Package Competitive comp package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a variety of plans available with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more! Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (“FDA”) for the treatment of relapsed/refractory (“R/R”) NPM1 -mutant acute myeloid leukemia (“AML”). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA’s acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date ofNovember 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1 -mutant and KMT2A -rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kura’s website at and follow us onX andLinkedIn . Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. If you are a California resident, please see the attached Privacy Notice CA Privacy Notice Apply for this job * indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School * Select. Degree * Select. Select. Select. Start date year End date month Select. End date year What is your preferred name? * Will you now or in the future require sponsorship for employment to work in the United States? * Select. Why do you want to work for Kura Oncology? If you were referred by a Kura employee, please share the name of who referred you. What are you salary expectations? Voluntary Self-Identification For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Kura Oncology’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select. Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form? We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury Disability Status Select. PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete. #J-18808-Ljbffr

Job Title: Associate Director, Clinical Regulatory Writing

Location: Boston, MA

Introduction to role:
Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-changing science into medicines. Our team provides expert communications leadership to drug projects, authoring strategically important clinical-regulatory documents that align with project strategies and regulatory requirements. We support AstraZenecas core therapeutic areas across all phases of clinical development, striving for excellence in communication to achieve successful submissions and approvals.

Accountabilities:

• As a Clinical Regulatory Writing Associate Director, you will:

• Independently manage clinical regulatory writing activities across a complex portfolio of work.

• Author the most complex clinical-regulatory documents within a program, ensuring regulatory, technical, and quality standards are met.

• Provide strategic communications leadership to projects, establishing communication standards and advocating for quality and efficiency.

• Drive the development of the clinical Submission Communication Strategy (cSCS) when acting as a submission lead.

• Lead internal/external authoring teams and partner with vendor medical writers to ensure timely and quality delivery.

• Interpret complex data and information, condensing it into clear, concise messages that meet customer information requirements.

• Demonstrate strategic thinking and review capabilities.

• Collaborate proactively with other functions at the program level.

• Support the development of Clinical Regulatory Writing Managers.

• Drive continuous improvement and operational excellence from a communications leadership perspective.
  
  Essential Skills/Experience:

• BS Life Sciences degree in an appropriate discipline.

• Significant (7+ yrs) medical writing experience in the pharmaceutical industry or CRO.

• Ability to advise and lead communication projects.

• Understand drug development and communication process from development, launch through life cycle management.

• In-depth knowledge of the technical and regulatory requirements related to the role.
  

Desirable Skills/Experience:

• Advanced degree in a scientific discipline (Ph.D.)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

AstraZeneca is where innovation meets collaboration. We harness diverse knowledge to move with agility, working seamlessly across functions globally. Our team is empowered to make quick decisions, influencing drug development strategy at all levels. With a science-driven approach, we bring life-changing medicines to patients, constantly asking questions and trying new things. Your professional growth is passionately supported here, with opportunities to work on projects at all stages of development.

Ready to make an impact? Apply now and be part of our dynamic team!

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Join to apply for the Director, Regulatory Writing (Temporary) role at Vir Biotechnology, Inc.

4 days ago Be among the first 25 applicants

Join to apply for the Director, Regulatory Writing (Temporary) role at Vir Biotechnology, Inc.

Vir Biotechnology is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

THE OPPORTUNITY

Vir Biotechnology is looking for a Regulatory Writing Director (Temporary Staff) who will support all aspects of regulatory submissions writing needs. They will collaborate with senior management and other leads to support consistent documents/messaging within and across programs.

This Person will report to the SVP, Regulatory.

This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.

What You'll Do

• Craft clear, accurate, and compliant documents required for regulatory submissions to global health authorities including FDA and EMA (European Medicines
• Write and edit a wide range of regulatory documents, including: Clinical trial protocols and amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing packages, regulatory submission dossiers (e.g., NDA, IND, MAA) and summary documents, such as summaries of safety and efficacy.
• Ensure all documentation adheres to relevant regulatory guidelines and standards, such as ICH E3 and ICH M4.
• Analyze complex scientific and medical information, including clinical trial data, and translating it into clear, concise, and accurate language understandable by both technical and non-technical audiences.
• Work closely with cross-functional teams (e.g., clinical, biostatistics, regulatory affairs, pharmacology, safety) to gather data and ensure comprehensive and accurate documentation.
• Manage writing projects from planning and coordination to submission, including establishing timelines and tracking progress.
  
  
  

• Preferred Bachelors Degree in Science or Medical related field with 15+ years industry experience, Masters Degree with 13+ years industry experience, or PhD with 10+ years industry experience.
• Experience with most of the more common regulatory documents such as CSRs, IBs, DSURs, protocols, and clinical modules.
• Expert understanding of eCTD structure and the clinical development process, and in-depth knowledge of document-related ICH guidelines and GxPs.
• Involvement with marketing applications (INDs, BLAs, NDAs, MAAs, or equivalents), preferably including responses to questions, 120-day safety updates, or other post-submission activities.
• At least 8 years of experience as a writer in biotechnology or equivalent.
  
  
  

• Seniority level Director

• Employment type Temporary

• Job function Other
• Industries Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Vir Biotechnology, Inc. by 2x

Get notified about new Director jobs in San Francisco, CA .

San Francisco, CA 150,000.00- 170,000.00 2 hours ago

San Francisco, CA 155,000.00- 165,000.00 6 days ago

San Francisco, CA 244,000.00- 373,000.00 2 weeks ago

San Francisco, CA 144,800.00- 219,300.00 2 days ago

San Mateo, CA 180,000.00- 300,000.00 1 week ago

San Mateo, CA 207,000.00- 297,000.00 1 week ago

San Francisco, CA 271,000.00- 408,000.00 2 days ago

San Francisco, CA 125,000.00- 135,000.00 5 days ago

San Francisco, CA 212,000.00- 265,000.00 3 days ago

San Francisco, CA 185,000.00- 255,000.00 6 days ago

San Francisco, CA 186,900.00- 257,000.00 5 days ago

San Mateo, CA 191,200.00- 274,850.00 5 days ago

San Mateo, CA 191,200.00- 274,850.00 5 days ago

San Francisco, CA 240,000.00- 270,000.00 3 days ago

San Francisco, CA 230,000.00- 325,000.00 2 days ago

San Mateo, CA 237,700.00- 341,665.00 4 days ago

San Francisco, CA 246,000.00- 290,000.00 4 days ago

San Mateo, CA 217,000.00- 301,000.00 1 week ago

San Mateo, CA 168,000.00- 276,000.00 5 days ago

San Bruno, CA 256,000.00- 352,500.00 5 days ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Join to apply for the Associate Director/Director, Medical & Regulatory Writing role at Kura Oncology, Inc.

3 days ago Be among the first 25 applicants

Join to apply for the Associate Director/Director, Medical & Regulatory Writing role at Kura Oncology, Inc.

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions. Essential Job Functions: Prepares, edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical summary experience a plus. Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed. Works closely with the study team to reach consensus on timelines for deliverables. Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments. Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs. Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency. May assist in providing oversight of vendors including contract writers, QC reviewers, and document formatters. Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents. Maintain current knowledge of industry trends and best practices for regulatory and scientific writing. Performs other duties as assigned. Job Requirements: Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required. PhD degree is preferred. Must have a minimum of 7+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred. Must have experience authoring clinical study reports, protocols, protocol amendments, Investigators Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus. Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view. Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission. Ability to manage competing priorities in a fast-paced environment. Excellent problem solving, organizational, and analytical critical thinking skills. Excellent written and verbal communication skills. Strong attention to detail related to consistency, grammar, syntax, and formatting. Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus. Proficient in MS Office Suite, EndNote, and Adobe Acrobat. Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva. Ability to travel up to approximately 10% of the time. The base range for an Associate Director is $175,183 - $04,532 per year and for a Director it is 215,889 - 241,291. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus. Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Companys pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (R/R) NPM1-mutant acute myeloid leukemia (AML). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDAs acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma. Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Health Care Provider

Referrals increase your chances of interviewing at Kura Oncology, Inc. by 2x

Waltham, MA 194,000.00- 213,000.00 2 months ago

Cambridge, MA 147,000.00- 212,333.33 1 week ago

Boston, MA 105,000.00- 134,000.00 4 days ago

Bedford, MA 144,000.00- 216,000.00 1 week ago

Marlborough, MA 180,400.00- 225,500.00 6 days ago

Cambridge, MA 204,600.00- 379,400.00 1 week ago

Boston, MA 168,000.00- 212,400.00 4 days ago

Waltham, MA 179,200.00- 224,000.00 6 days ago

Watertown, MA 300,000.00- 400,000.00 2 weeks ago

Boston, MA 265,000.00- 285,000.00 2 days ago

Marlborough, MA 180,400.00- 225,500.00 1 week ago

Waltham, MA 194,000.00- 213,000.00 4 days ago

Waltham, MA 222,500.00- 261,700.00 1 day ago

Boston, MA 231,900.00- 347,800.00 2 weeks ago

United States 175,183.00- 204,532.00 3 days ago

Boston, MA 156,000.00- 234,000.00 2 weeks ago

Waltham, MA 215,000.00- 246,000.00 2 months ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

Essential Job Functions

• Prepares, edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical summary experience a plus.
• Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
• Works closely with the study team to reach consensus on timelines for deliverables.
• Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• May assist in providing oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for regulatory and scientific writing.
• Performs other duties as assigned

Job Requirements

• Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required. PhD degree is preferred.
• Must have a minimum of 7+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigators Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission.
• Ability to manage competing priorities in a fast-paced environment.
• Excellent problem solving, organizational, and analytical critical thinking skills.
• Excellent written and verbal communication skills.
• Strong attention to detail related to consistency, grammar, syntax, and formatting.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus.
• Proficient in MS Office Suite, EndNote, and Adobe Acrobat.
• Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva.
• Ability to travel up to approximately 10% of the time.

The base range for an Associate Director is $175,183 - $04,532 per year and for a Director it is 215,889 - 241,291. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

Kuras Values that are used for candidate selection and performance assessments:

• We work as one for patients
• We are goal-focused and deliver with excellence
• We are science-driven courageous innovators
• We strive to bring out the best in each other and ourselves

The Kura Package

• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Companys pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (R/R) NPM1 -mutant acute myeloid leukemia (AML). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDAs acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date ofNovember 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1 -mutant and KMT2A -rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kuras website at and follow us onX andLinkedIn .

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School * Select.

Degree * Select.

Select.

Select.

Start date year

End date month Select.

End date year

What is your preferred name? *

Will you now or in the future require sponsorship for employment to work in the United States? * Select.

Why do you want to work for Kura Oncology?

If you were referred by a Kura employee, please share the name of who referred you.

What are you salary expectations?

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Kura Oncologys Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjus

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

Essential Job Functions

• Prepares, edits, and finalizes synopses, protocols, protocol amendments, investigator brochures, regulatory documents, and related clinical documents. Module 2 clinical summary experience a plus.
• Collaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
• Works closely with the study team to reach consensus on timelines for deliverables.
• Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments.
• Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.
• Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.
• May assist in providing oversight of vendors including contract writers, QC reviewers, and document formatters.
• Must have proficiency in the use of EndNote or RightFind Cite It software for the citation of literature references and creation of list of references in Word documents.
• Maintain current knowledge of industry trends and best practices for regulatory and scientific writing.
• Performs other duties as assigned

Job Requirements

• Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required. PhD degree is preferred.
• Must have a minimum of 7+ years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Oncology experience preferred.
• Must have experience authoring clinical study reports, protocols, protocol amendments, Investigators Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus.
• Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view.
• Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission.
• Ability to manage competing priorities in a fast-paced environment.
• Excellent problem solving, organizational, and analytical critical thinking skills.
• Excellent written and verbal communication skills.
• Strong attention to detail related to consistency, grammar, syntax, and formatting.
• Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus.
• Proficient in MS Office Suite, EndNote, and Adobe Acrobat.
• Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva.
• Ability to travel up to approximately 10% of the time.

The base range for an Associate Director is $175,183 - $04,532 per year and for a Director it is 215,889 - 241,291. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

#LI-RM1

Kuras Values that are used for candidate selection and performance assessments:

• We work as one for patients
• We are goal-focused and deliver with excellence
• We are science-driven courageous innovators
• We strive to bring out the best in each other and ourselves

The Kura Package

• Competitive comp package
• Bonus
• 401K + Employer contributions
• Generous stock options
• ESPP Plan
• 20 days of PTO to start
• 18 Holidays (Including Summer & Winter Break)
• Generous Benefits Package with a variety of plans available with a substantial employer match
• Paid Paternity/Maternity Leave
• In-Office Catered lunches
• Home Office Setup
• Lifestyle Spending Stipend
• Commuter Stipend (Boston Office)
• Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Companys pipeline consists of small molecule drug candidates designed to target cancer signaling pathways. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory (R/R) NPM1 -mutant acute myeloid leukemia (AML). In November 2024, Kura Oncology entered into a global strategic collaboration agreement with Kyowa Kirin Co., Ltd. to develop and commercialize ziftomenib for AML and other hematologic malignancies. Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1 -mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDAs acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1 -mutant AML and assignment of a Prescription Drug User Fee Act target action date ofNovember 30, 2025. Kura Oncology and Kyowa Kirin are also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1 -mutant and KMT2A -rearranged AML. KO-2806, a next-generation farnesyl transferase inhibitor, is being evaluated in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies for patients with various solid tumors. Tipifarnib, a potent and selective farnesyl transferase inhibitor, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA -dependent head and neck squamous cell carcinoma. For additional information, please visit Kuras website at and follow us onX andLinkedIn .

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

If you are a California resident, please see the attached Privacy Notice CA Privacy Notice

Create a Job Alert

Interested in building your career at Kura Oncology? Get future opportunities sent straight to your email.

*

indicates a required field

First Name *

Last Name *

Email *

Phone *

Resume/CV *

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Education

School * Select.

Degree * Select.

Select.

Select.

Start date year

End date month Select.

End date year

What is your preferred name? *

Will you now or in the future require sponsorship for employment to work in the United States? * Select.

Why do you want to work for Kura Oncology?

If you were referred by a Kura employee, please share the name of who referred you.

What are you salary expectations?

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Kura Oncologys Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veteran

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for a Manager, Regulatory Medical Writing to support one or more of our therapeutic areas in within the X-TA Regulatory Medical Writing unit, Integrated Data Analytics & Reporting (IDAR) business.

The position may be in the UK (High Wycombe), Belgium (Beerse), Netherlands (Leiden) or the United States (Raritan, Springhouse or Titusville). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

The position is Hybrid (3 days onsite weekly). Remote work options may be considered on a case-by-case basis and if approved by the company

Are you ready to join our team? Then please read further!

• Preparing and finalizing all types of clinical documents independently within and across therapeutic areas (TAs).
• Leading in a team environment. Working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking. May consult with more senior colleagues on complex situations.
• Lead and actively participate in setting functional tactics/strategy as needed.
• Oversee the work of external contractors
• Leading or setting objectives for others on team projects and tasks, eg, leading process working groups.
• Guiding or training cross-functional team members on processes and best practices.
• Potentially leading project-level/submission/indication writing teams.
• If a lead writer for a program/compound (or submissions, indications, or disease areas): act as the primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for assigned program.
• Actively participating in medical writing and cross-functional meetings.
• Proactively provide recommendations for departmental process improvements.
• Maintaining knowledge of industry, company, and regulatory guidelines.
• Coaching or mentoring more junior staff on document planning, processes, content, and provide peer review as needed, overseeing the work of other medical writers, external contractors, and document specialists supporting a project.
• Interacting with senior cross-functional colleagues to strengthen coordination between departments.
• Representing Medical Writing department in industry standards working groups if and as needed.
• Complete all time reporting, training, and metrics database updates as required in relevant company systems.

• If a people manager:
  • Manage a team of internal medical writers (direct reports).
  • Setting objectives for individual team members, conducting career and talent development discussions for staff, lead in goal setting, and performance discussions.
  • Regularly meeting with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
  • Ensures direct report’s adherence to established policies, procedural documents, and templates.
  • Accountable for the quality of deliverables and for compliance of direct reports.
  • Participate in resource management and hiring decisions.

• University/college degree required. Masters or PhD preferred.
• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required!
• If a people manager, preferably up to 2 years of people management experience.

Other Requirements:

• Experience of multiple therapeutic areas preferred.
• Attention to detail.
• Excellent oral and written communication skills are pivotal to engage in cross-functional discussions. English fluency required.
• Expert project/time management skills.
• Strong project/process leadership skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
• Able to resolve complex problems independently.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‐functional team members.
• Solid knowledge and application of regulatory guidance documents such as ICH requirements.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-020998

Netherlands, Belgium- Requisition Number: R-021535

United States - Requisition Number: R-021538

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

The anticipated base pay range for this position is $115,000 to $97,000 (USD).

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

- Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

- Holiday pay, including Floating Holidays - up to 13 days per calendar year

- Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

#LI-Hybrid

#LI-Remote

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: