New · posted Oct 31
Kiniksa Pharmaceuticals International · Pharmaceuticals
Director, Medical Writing
- Lexington, MA
- On-site
- Full-time
- Director
The role
Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.
Kiniksa Pharmaceuticals is seeking a highly experienced Director, Medical Writing to serve as a senior individual contributor supporting clinical development programs through clear, high-quality, and scientifically robust medical writing.
This role is central to delivering clinical narratives that are accurate, aligned, and impactful, enabling teams to make informed decisions and advance programs efficiently. In addition to leading document development, the Director will contribute to the evolution of the medical writing function’s strategy, helping drive quality, speed, and consistency across the portfolio.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
What you need
Standout Skills for Impact
Key Competencies
- Exceptional scientific writing and storytelling ability
- High attention to detail with a focus on clarity and usability
- Ability to influence without authority and drive alignment
- Strong ownership mindset and ability to work autonomously
- Continuous improvement and solution-oriented thinking
This role directly contributes to
- Higher-quality documents with fewer review cycles
- Faster delivery timelines through better alignment and execution
- Clear, consistent clinical narratives across programs
- Enabling teams to focus on science while ensuring content is right, ready, and impactful
Qualifications and Experience
- Degree in life sciences or related field
- 8–12+ years of experience in medical/clinical writing in biopharma or CRO
- Demonstrated expertise in authoring complex clinical documents independently
- Thorough knowledge of drug development, ICH guidelines, Good Clinical Practice, CTD/eCTD organization, health authority expectations, and relevant pharmaceutical regulations
- Strong ability to synthesize and communicate complex data clearly
- Experience working in cross-functional clinical development teams
- Excellent communication, organization, and stakeholder management skills
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
What you'll do
Responsibilities (including, but not limited to)
Clinical & Medical Writing Leadership
- Lead the planning, authoring, and review of key clinical documents, including:
- Clinical study reports (CSRs)
- Protocols and amendments
- Investigator’s Brochures (IBs)
- Clinical summaries and other program-level deliverables
- Translate complex clinical and statistical data into clear, concise, and scientifically compelling narratives
- Serve as a trusted writing expert within cross-functional teams
Scientific Quality & Narrative Excellence
- Ensure all documents meet the highest standards for clarity, accuracy, consistency, and interpretability
- Drive alignment of clinical messaging and data interpretation across documents and stakeholders
- Minimize rework through thoughtful structuring, early alignment, and strong storytelling
Cross-Functional Partnership
- Partner closely with Clinical Development, Clinical Operations, Biostatistics, and Safety to:
- Align early on document strategy and key messages
- Ensure consistency across program communications
- Facilitate efficient review cycles and timely delivery
- Act as a bridge between data and communication, enabling teams to focus on science while ensuring content excellence
Medical Writing Function Strategy & Excellence
- Contribute to the evolution of the medical writing function, aligned with the writing departments principles of:
- Working together: building strong partnerships and early alignment
- Doing it right: embedding quality into all deliverables
- Moving fast: enabling efficient, timely document delivery
- Support development and refinement of templates, tools, and best practices
- Help drive initiatives that improve:
- Document quality and consistency
- Speed and efficiency of delivery
- Cross-program alignment of messaging
Process Improvement & Ways of Working
- Identify opportunities to simplify processes and reduce review burden
- Contribute to a culture of clear ownership, accountability, and continuous improvement
- Provide guidance to peers and external partners to elevate overall writing capability
Pay
$225,000 – $239,000 a year
Employer provided$225,000—$239,000 USD
Where you'll work
Lexington, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesKiniksa Pharmaceuticals International's statements, word for word
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 12% above the US median for Clinical Evaluation & Medical Writing roles at this level.
This roleEmployer provided
Director roles in Massachusetts5 roles publishing pay
Director roles in the US9 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $225,000 | — | $239,000 |
| Massachusetts (middle half) | $195,000 | $197,000 | $225,000 |
| All US (middle half) | $195,000 | $206,500 | $225,000 |
This role: Kiniksa Pharmaceuticals International's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Evaluation & Medical Writing
The general path across 21 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not Kiniksa Pharmaceuticals's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 55 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs18
- Collaboration and leadership13
- Clinical trial conduct7
- Quality systems and risk3
- Investigations and CAPA2
- GMP and compliance1
- Regulatory submissions1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
Kiniksa Pharmaceuticals on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 1
- Locations
By discipline
- Clinical4 50%
- Regulatory2 25%
- Quality2 25%
By level
- Director5 63%
- VP & Executive1 13%
- Manager1 13%
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Director, Medical Writing at Kiniksa Pharmaceuticals
Open until filled. $225K–$239K a year, employer provided.