Associate Director - Medical Writing

9+ years

Not Disclosed

Lexington United States

10 Feb. 13, 2025

Job Description

Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Associate Director, Medical Writing

Location: Lexington, United States
Job Category: Clinical Development

About the Department

Our East Coast Global Development Hub unites the best minds in life science innovation with facilities in Lexington, MA, and Plainsboro, NJ. We support programs from early research through late-stage clinical development, combining biotech speed with large pharmaceutical resources and stability. We are dedicated to improving human health and developing new medicines for patients.

The Position

The Associate Director, Medical Writing (ADMW) is an expert in medical writing who works independently with minimal supervision. This role involves collaborating with cross-functional project teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs, to develop written deliverables supporting clinical development and regulatory requirements. The Associate Director provides strategic input into development plans, study designs, and regulatory submissions.

Key Responsibilities

Strategic Input & Document Preparation

Provide expert-level input into study designs, analysis plans, and regulatory submissions.
Assess study plans and related documents to ensure they deliver the necessary information for the target audience.
Collaborate with teams to develop key messages for complex clinical and regulatory documents.
Author, review, and edit documents, including:
- Clinical summary and overview documents for global regulatory submissions (IMPD, IND, CTA, MAA, NDA).
- Regulatory meeting deliverables (briefing books, slides, minutes).
- Clinical study protocols, amendments, and reports (CSR).
- Investigator brochures (IB), informed consent forms, and lay summaries.
- Pediatric investigational plans (PIP), orphan drug applications, and breakthrough therapy designation requests.

Process Improvement & Leadership

Share best practices and contribute to process improvements within the medical writing team.
Promote awareness of medical writing practices and set medical writing standards.
Lead meetings and drive decisions regarding project-specific medical writing issues.
Provide mentorship and guidance to less-experienced medical writers.

General Responsibilities

Interpret and present clinical and statistical data clearly and concisely.
Identify and resolve complex medical writing-related problems.
Maintain up-to-date knowledge of regulatory guidelines, industry standards, and company policies.

Physical Requirements

Approximately 10% overnight travel, including international travel.

Development of People

Supervisory Responsibilities:

Ensure direct reports have individual development plans (IDP) with clear goals and measurements.
Provide interim reviews to align work with business priorities.
Manage and communicate company policies, procedures, and Novo Nordisk’s core values.

Qualifications

Education:

Minimum of a BS/BA in a health-related or scientific discipline.

Experience:

9+ years of relevant experience, including at least 8 years in clinical/regulatory medical writing within a pharmaceutical, biotechnology, or CRO environment.
Experience contributing to drug applications with FDA and EMA (experience in Japan and China is a plus).
Strong understanding of clinical research, drug/device development processes, and regulatory guidelines.
Expertise in statistical approaches to clinical study design and analysis.
Therapeutic area experience with cell therapies or other advanced therapeutics is preferred.

Skills & Competencies:

Strong collaboration skills across global time zones.
Exceptional written and oral communication skills with mastery of English grammar and punctuation.
Ability to manage multiple projects and meet deadlines efficiently.

Equal Opportunity Employer

Novo Nordisk is committed to an inclusive recruitment process and equal employment opportunities for all applicants. We celebrate diversity and strive to create an inclusive culture for our employees, patients, and the communities we serve.

Qualified applicants will receive consideration without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by law.

Accommodation Requests: If you require assistance or accommodation to apply, please call 1-855-411-5290 (for accommodation requests only; inquiries about application status will not be accepted).

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