Talent.com
ADARx Pharmaceuticals, Inc. is hiring: Senior Medical Writer in San Diego
ADARx Pharmaceuticals, Inc. is hiring: Senior Medical Writer in San DiegoMediabistro • San Diego, CA, United States
ADARx Pharmaceuticals, Inc. is hiring : Senior Medical Writer in San Diego

ADARx Pharmaceuticals, Inc. is hiring : Senior Medical Writer in San Diego

Mediabistro • San Diego, CA, United States
1 day ago
Job type
  • Full-time
Job description

We are seeking a highly motivated and qualified contributor to join ADARx Pharmaceuticals as an Sr. Medical Writer to lead medical writing strategies and deliverables aligned with clinical and regulatory goals and execution across clinical development programs. The successful candidate will provide scientific writing support through clinical development, regulatory submissions, and post-marketing activities. This role is ideal for an individual who thrives in a fast-paced, high-growth environment and is passionate about making a meaningful impact in drug development.

Essential Responsibilities :

  • Lead the planning, authoring, and on-time delivery of clinical and regulatory documents in accordance with the corporate timeline, including :

Clinical trial protocols / amendments

  • Clinical Study Reports (CSRs)
  • Investigator's Brochures (IBs)
  • Regulatory submission documents (IND / CTA, NDA / BLA / MAA, briefing books)
  • Clinical summaries for eCTD modules
  • Conduct version management and tracking of drafts and final document and ensure compliance with global regulatory standards (e.g. FDA, EMA, ICH-GCP).
  • Verify 100% accuracy of data against source documents
  • Coordinating with document management systems and archiving finalized documents for audits and inspections in partnership with Regulatory and Quality function.
  • Develop and maintain templates, style guides, and best practices for medical writing tailored to RNA-based drug development for ADARx portfolio.
  • Collaborate with clinical operations, clinical development, biostatistics, regulatory affairs, safety, and CMC teams to align timelines and messaging complex scientific data into clear and compliant content.
  • Responsible for authoring protocols, IBs, CSRs, and regulatory submissions with scientific accuracy and strategic alignment.
  • Support preparation and delivery of scientific presentations and publications (abstracts / posters), investigator meetings, and advisory boards.
  • Oversee internal and external medical writing teams, as applicable, including CRO partners, ensuring compliance with regulatory standards (e.g., FDA, EMA, ICH). Evaluates and manages CRO for applicable scope, timelines and deliverables.
  • Mentor and develop junior medical writers, while contributing to building medical writing capabilities and infrastructure within the company for exceptional cross-functional collaboration.
  • Stay current with evolving regulatory requirements, industry trends, and methodological innovations relevant to medical writing with special focus on RNA therapeutics.
  • Drive continuous improvement of processes, tools, and workflows to increase efficiency and quality.
  • Creates, maintains, and implements SOPs, processes, standards, and work instructions with respect to medical writing to ensure compliance, accuracy, and efficiency.
  • Act as a scientific and communication bridge between Discovery and Clinical Development teams.
  • Essential Physical Characteristics :

    Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis.

    On-Site Protocol :

    Physical presence at the ADARx Pharmaceuticals worksite is preferred, although remote candidates will be considered for this role. The Company deems full critical engagement to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

    Qualifications :

  • Advanced degree in life sciences (PhD, PharmD or MSc) with strong background in molecular biology, pharmacology, or related fields preferred.
  • 5+ years of experience in biotech / pharmaceutical industry with medical writing responsibilities.
  • Expertise in regulatory writing and clinical development for RNA therapeutics, oligonucleotides, gene therapies, or biologics (strongly preferred).
  • Proven track record contributing to or leading major regulatory submissions (IND / CTA, NDA / BLA / MAA).
  • Strong understanding of clinical trial design, pharmacology, and RNA-specific therapeutic considerations (delivery, immunogenicity, biodistribution).
  • Exceptional communication, writing, and editing skills with the ability to distill complex science for diverse audiences while incorporating input from cross functional subject matter experts (SMEs).
  • Leadership experience is preferred
  • Strategic thinker with the ability to integrate clinical science and regulatory strategy with SMEs.
  • Passion for advancing RNA-based therapies to address unmet medical needs.
  • Comfortable working in a fast-paced, entrepreneurial biotech environment
  • Required Key Attributes :

  • Must be able to work independently with supervision as needed.
  • Must be collaborative, work well with other Clinical Development team members in a matrix team environment.
  • Excellent written and verbal communication skills are essential for this role.
  • Strong organizational skills with attention to detail and accuracy.
  • Ability to maintain a high level of confidentiality and exercise discretion.
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges.
  • Understand project timelines and deliverables and plans / coordinate project work accordingly with departmental, functional, and external stakeholders.
  • Compensation :

  • This is a full-time position, Monday-Friday.
  • Pay is commensurate with experience.
  • Equity-based compensation
  • Performance-based bonuses
  • 401(k) with Company Match
  • Medical, Dental, Vision
  • Flexible Spending Account
  • Life Insurance
  • Employee Assistance Program
  • Employee Discounts
  • Gym Membership
  • Paid Vacation
  • Paid Holidays
  • Paid Sick, Jury Duty, Bereavement
  • Work Authorization :

  • United States (Required)
  • Background Check
  • As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check.
  • Company Overview :

    ADARx Pharmaceuticals, Inc., (the "Company" or "ADARx") located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system.

    ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors.

    ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

    Disclosure Statement

  • The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
  • Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
  • The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law.
  • Total Compensation includes base salary; benefits : medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses.
  • Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and / or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.
  • Create a job alert for this search

    Inc Is Hiring Senior • San Diego, CA, United States

    Related jobs
    Job Medical Assistant

    Job Medical Assistant

    Vista Community Clinic • Escondido, CA, US
    Full-time
    Job Opportunity At Vista Community Clinic.Vista Community Clinic is a private, non-profit, multi-specialty outpatient clinic providing care in a comprehensive, high quality setting.Located in San D...Show more
    Last updated: 30+ days ago • Promoted
    Medical Technical Writer Job at People, Technology & Processes, LLC in San Diego

    Medical Technical Writer Job at People, Technology & Processes, LLC in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    Overview Position title : Medical Technical Writer Location : Coronado, CA Clearance level required : Secret or above Responsibilities Develop, write, revise, and edit reports, articles, manual...Show more
    Last updated: 30+ days ago
    Insight Global is hiring : Senior Technical Writer in San Diego

    Insight Global is hiring : Senior Technical Writer in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    We are looking for a Senior Technical Writer to sit onsite in San Diego, CA for one of our client.The Senior Technical Writer will research, create, and edit operational, instructional, maintenance...Show more
    Last updated: 3 days ago
    Senior Content Writer - 100% Remote Job at Valid8 Financial, Inc. in San Diego

    Senior Content Writer - 100% Remote Job at Valid8 Financial, Inc. in San Diego

    Mediabistro • San Diego, CA, United States
    Remote
    Full-time
    Established in 1999, BOL is an award-winning B2B marketing agency.Our tech-forward approach keeps us at the cutting edge of innovation, always leveraging the latest tools to accelerate impact.At th...Show more
    Last updated: 17 days ago
    Nexus Contingent Workforce is hiring : Senior Medical Writer in San Diego

    Nexus Contingent Workforce is hiring : Senior Medical Writer in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    We are seeking a highly qualified and experienced Senior Medical Writer to join our team.The ideal candidate will have over 10 years of experience in medical writing, with a proven track record of ...Show more
    Last updated: 30+ days ago
    Ionis Pharmaceuticals is hiring : Principal Medical Writer - Regulatory and Medic

    Ionis Pharmaceuticals is hiring : Principal Medical Writer - Regulatory and Medic

    Mediabistro • Carlsbad, CA, United States
    Full-time
    Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have...Show more
    Last updated: 30+ days ago
    Edwards Lifesciences is hiring : Senior Specialist, Medical Writing in San Diego

    Edwards Lifesciences is hiring : Senior Specialist, Medical Writing in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    Imagine how your ideas and expertise can change a patient’s life.We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transfor...Show more
    Last updated: 16 days ago
    Valid8 Financial, Inc. is hiring : Senior Content Writer - 100% Remote in San Die

    Valid8 Financial, Inc. is hiring : Senior Content Writer - 100% Remote in San Die

    Mediabistro • San Diego, CA, United States
    Remote
    Full-time
    Established in 1999, BOL is an award-winning B2B marketing agency.Our tech-forward approach keeps us at the cutting edge of innovation, always leveraging the latest tools to accelerate impact.At th...Show more
    Last updated: 14 days ago
    Senior Specification Writer Job at Perkins&Will in San Diego

    Senior Specification Writer Job at Perkins&Will in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    Join to apply for the Senior Specification Writer role at Perkins&Will 1 day ago Be among the first 25 applicants Join to apply for the Senior Specification Writer role at Perkins&Will Works ...Show more
    Last updated: 30+ days ago
    Senior Technical Writer Job at Insight Global in San Diego

    Senior Technical Writer Job at Insight Global in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    Overview Job Description We are looking for a Senior Technical Writer to sit onsite in San Diego, CA for one of our client. The Senior Technical Writer will research, create, and edit operational, ...Show more
    Last updated: 1 day ago
    Automotive Service Writer

    Automotive Service Writer

    TradeJobsWorkForce • 92131 San Diego, CA, US
    Full-time
    Automotive Service Writer Job Duties : Initiates automotive services and repairs by ascertaining performance probl...Show more
    Last updated: 30+ days ago • Promoted
    Automotive Service Writer

    Automotive Service Writer

    TradeJobsWorkforce • 92167 San Diego, CA, US
    Full-time
    Automotive Service Writer Job Duties : Initiates automotive services and repairs by ascertaining performance proble...Show more
    Last updated: 30+ days ago • Promoted
    Dedicated Writer

    Dedicated Writer

    TradeJobsWorkForce • 92109 San Diego, CA, US
    Full-time
    Dedicated Writer Job Duties : Computer with internet access Office 365 or Microsoft Office Suite Mo...Show more
    Last updated: 30+ days ago • Promoted
    Medical Writing Manager / Sr. Medical Writing Manager Job at Neurocrine Bioscience

    Medical Writing Manager / Sr. Medical Writing Manager Job at Neurocrine Bioscience

    Mediabistro • San Diego, CA, United States
    Full-time
    Overview Who We Are : At Neurocrine Biosciences, we pride ourselves on a strong, inclusive, and positive culture based on our shared purpose and values. We are passionate about people and our missio...Show more
    Last updated: 29 days ago
    Firestorm is hiring : Senior Technical Writer in San Diego

    Firestorm is hiring : Senior Technical Writer in San Diego

    Mediabistro • San Diego, CA, United States
    Permanent
    About The Role : At Firestorm Labs, driving business growth and equipping end-users with clear, effective documentation is essential to mission success. As a Senior Technical Writer supporting our Ad...Show more
    Last updated: 30+ days ago
    Sr Medical Affairs Specialist - Regulatory Writing and Scientific Communications

    Sr Medical Affairs Specialist - Regulatory Writing and Scientific Communications

    Mediabistro • San Diego, CA, United States
    Full-time
    Overview Sr Medical Affairs Specialist – Regulatory Writing and Scientific Communications.Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM).We ...Show more
    Last updated: 3 days ago
    Technical Writer

    Technical Writer

    TradeJobsWorkForce • 92103 San Diego, CA, US
    Full-time
    Research, write, edit and proofread complex technical data.Create, maintain and update manuals, procedures, specifications and other documents. Create, maintain and update installation instructions,...Show more
    Last updated: 30+ days ago • Promoted
    Philips is hiring : Medical Writer in San Diego

    Philips is hiring : Medical Writer in San Diego

    Mediabistro • San Diego, CA, United States
    Full-time
    The Medical Writer for the Sleep & Respiratory Care business will primarily focus on and be responsible for authoring and maintaining Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (...Show more
    Last updated: 1 day ago