Associate Director-Medical Writer

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 128,000 - 187,000; Full time

Benefits offered by this job

Company bonus

401(k) and pension

Vacation benefits

Medical, dental, vision coverage

Flexible benefits

Well-being benefits

Job summary

Lilly seeks an experienced medical writer to lead planning, authoring, and review of complex clinical and regulatory documents across development programs, collaborating with clinical development, regulatory affairs, biostatistics, medical affairs, and legal to ensure scientific accuracy and regulatory compliance.

The ideal candidate holds a bachelor’s degree in a scientific field (Master’s or PhD preferred) and at least eight years of medical writing experience in pharma/biotech/CRO, with

Qualifications

• Experience writing regulatory documents (CSRs, IBs, protocols, submissions).
• Strong understanding of drug development, trial design, biostatistics, and regulations.

Responsibilities

• Lead planning, authoring, and review of complex clinical and regulatory documents.
• Manage multiple writing projects concurrently with cross-functional teams.
• Synthesize data into clear, concise regulatory communications.
• Mentor junior writers and contribute to writing standards.

Skills

Regulatory writing

Document management

Scientific writing

Education

Bachelor's degree in a relevant scientific field

Master's or PhD preferred

Tools

Microsoft Office Suite

Document management systems

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life‑changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Verve Therapeutics, a Lilly Research Labs subsidiary, is a clinical‑stage genetic medicines company on a mission to solve cardiovascular disease. Founded by leaders in cardiovascular medicine and gene editing, Verve is developing one‑time gene editing treatments aimed at turning chronic management into a single‑course cure. Its lead programs target PCSK9 and ANGPTL3 to lower LDL-C, the root cause of cardiovascular disease.

Job Responsibilities

• Lead the planning, authoring, and review of complex clinical and regulatory documents, including but not limited to Clinical Protocols, Investigator's Brochures (IBs), Clinical and Nonclinical Investigational Medicinal Product Dossiers (IMPDs), regulatory submission documents (e.g., IND/NDA/BLA modules), Clinical Study Reports (CSRs), and briefing documents.
• Manage multiple writing projects concurrently, ensuring prompt delivery and quality of all assigned documents.
• Collaborate effectively with cross‑functional teams, including clinical development, regulatory affairs, biostatistics, medical affairs, nonclinical, and legal, to gather necessary information and ensure scientific accuracy and consistency across documents.
• Interpret and synthesize complex scientific and clinical data from various sources into clear, concise, and scientifically sound written communications.
• Provide strategic input on document content and messaging, ensuring alignment with project objectives and regulatory requirements.
• Mentor and provide guidance to junior medical writers, fostering their professional development.
• Develop and maintain a strong understanding of relevant therapeutic areas, drug development processes, and applicable regulatory guidelines (e.g., ICH, FDA, EMA).
• Engage in the development and implementation of medical writing standards, templates, and guidelines.
• Represent medical writing at internal and external meetings.

Basic Qualifications

• Bachelor's degree in a relevant scientific field required; Master's or PhD preferred.
• Minimum of 8 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry.

Additional Skills/Preferences

• Demonstrated expertise in authoring a wide range of regulatory documents (CSRs, IBs, protocols, regulatory submissions).
• Strong understanding of drug development processes, clinical trial design, biostatistics, and regulatory requirements.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management systems.
• Experience in leading or mentoring junior writers is highly desirable.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

The anticipated wage for this position is $127,500 - $187,000.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

In addition, Lilly offers a comprehensive benefit program to eligible employees, including

• company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

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