Job Functions1. Clinical Study Protocol Writing2. Regulatory Document Preparation3. Data Interpretation and Presentation4. Project Management5. CrossFunctional Collaboration
Job Requirements1. Doctorallevel degree in Life Sciences or Master’s degree with relevant experience2. Substantial clinical study protocol writing experience desired3. Excellent communication, presentation, and project management skills4. Working knowledge of statistical concepts and techniques5. Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus
Skills1. Medical Writing2. Scientific Knowledge3. Attention to Detail4. Process Improvement5. Technical Expertise1. Independent Work Ethic2. Strong Communication Skills3. Proactive ProblemSolving4. Collaborative Mindset5. Time Management
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ), New York City (NYC) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You’ll Do
- Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
- Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
- Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
- Help to iteratively improve medical writing processes as appropriate.
- Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
- Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
- Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope.
Qualifications
- Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master’s degree with 3+ years of relevant experience, or Bachelor’s degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
- Substantial clinical study protocol writing experience desired.
- Excellent communication, presentation, and project management skills.
- Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
- Working knowledge of statistical concepts and techniques.
- Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
- Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
- Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
- Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
- Familiarity with concepts of structured content management preferred.
- Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
- 401k plan with company matching
- Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
- Mental health and wellness benefits
- Weeklong summer and winter holiday shutdowns
- Generous paid time off and holiday policies
- Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
- Enhanced parental leave benefit
- Daily subsidized lunch program when on-site
The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Life at Eikon Therapeutics
Thrive Here & What We Value1. Passion for innovation and improving patient outcomes. | 2. Daily subsidized lunch program when onsite. | 3. Generous paid time off and holiday policies. | 4. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 5. Enhanced parental leave benefit. | 6. Weeklong summer and winter holiday shutdowns. | 7. Mental health and wellness benefits.</s> | Equal Opportunity Employer | Generous Benefit Programs | Daily Subsidized Lunch Program</s> | Eikon Therapeutics is committed to creating a positive and inclusive workplace culture that values collaboration, innovation, and creativity. | The company offers generous benefits programs, including 401k plan with company matching, medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies. | Daily subsidized lunch program when on-site | Enhanced parental leave benefit</s> | 1. Innovative and forwardthinking approach to drug discovery | 2. Emphasis on collaboration and teamwork | 3. Focus on creating novel treatments for lifethreatening diseases | 4. Commitment to equal opportunity employment | 5. No thirdparty agencies or firms currently being considered</s> | 1. Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for lifethreatening diseases. | 2. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | 3. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching, Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), Mental health and wellness benefits, Weeklong summer and winter holiday shutdowns, Generous paid time off and holiday policies, Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies, Enhanced parental leave benefit, Daily subsidized lunch program when on-site.</s> | 2. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecularresolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | Eikon Therapeutics is committed to discovering novel treatments for life-threatening diseases using groundbreaking innovations from its founders. | The company's discovery platform is built on revolutionary technology at the intersection of Chemistry, Engineering, Computation, and Biology. | Eikon values collaboration, agility, and operational excellence in building and leading in-house clinical operations study management teams.</s> | Mental health and wellness benefits</s> | 1. Eikon Therapeutics is an equal opportunity employer and will consider all qualified applicants for employment. | 2. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 3. Daily subsidized lunch program when onsite. | 4. Weeklong summer and winter holiday shutdowns. | 5. Generous paid time off and holiday policies. | 6. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 7. Enhanced parental leave benefit.</s> | Eikon Therapeutics is committed to creating an inclusive culture that values diverse perspectives, experiences, and backgrounds. | The company offers generous benefits programs, including medical, dental, and vision insurance, mental health and wellness benefits, paid time off, holiday policies, life/AD&D Insurance, parental leave benefit, and daily subsidized lunch program when on-site.</s> | 3. Focus on making a positive impact on patients' lives through novel treatments for lifethreatening diseases | 4. Supportive and inclusive work environment | 5. Opportunities for professional growth and development</s> | 1. Eikon Therapeutics is committed to creating a diverse and inclusive workplace culture that values collaboration, innovation, and excellence. | 2. The company offers generous benefits programs, including 401k plan with company matching, medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies. | 3. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.</s> | 1. Employee compensation includes bonus and equity compensation, in addition to several generous benefit programs. | 2. Generous paid time off and holiday policies | 3. Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employeepaid life/AD&D policies | 4. Enhanced parental leave benefit | 5. Daily subsidized lunch program when onsite</s> | 3. Focus on improving patient outcomes through novel treatments | 4. Commitment to scientific excellence and integrity | 5. Support for professional development and growth</s> | Generous benefit programs, including 401k plan with company matching, medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) | Daily subsidized lunch program when on-site</s> | 1. Dedication to promoting a culture of safety, sustainability, and compliance in a dynamic biotech environment | 2. Generous benefit programs, including 401k plan with company matching, medical, dental, and vision insurance, mental health and wellness benefits, weeklong summer and winter holiday shutdowns, paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%), enhanced parental leave benefit, daily subsidized lunch program when onsite.</s> | Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. | Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. | At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%), mental health and wellness benefits, weeklong summer and winter holiday shutdowns, generous paid time off and holiday policies, life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies, enhanced parental leave benefit, daily subsidized lunch program when on-site.</s> | 2. Collaborative and supportive environment | 3. Emphasis on teamwork and communication | 4. Focus on making a positive impact in the world through novel treatments for lifethreatening diseases | 5. Commitment to equal opportunity employment</s> | 1. Equal Opportunity Employer | 5. Enhanced Parental Leave Benefit</s>
