Senior Medical Writer

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:

On-Site Protocol:

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 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. 135000.00 To 187000.00 (USD) Annually