Associate Director - Medical Writing

9+ years

Not Disclosed

Lexington

10 Jan. 8, 2025

Job Description

Job Type: Full Time Education: BS/BA 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 Title: Associate Director, Medical Writing

Location: Lexington, MA / Plainsboro, NJ (East Coast Global Development Hub)
Company: Novo Nordisk

About the Department

Our East Coast Global Development Hub unites life science innovation with facilities in Lexington, MA, and Plainsboro, NJ. This hub supports clinical programs from early research through late-stage development, fostering collaboration, partnerships, and cutting-edge research.

Merging the speed of biotech with the quality and stability of a large pharmaceutical company, our team is dedicated to improving human health through the development of innovative medicines. Are you ready to make a difference?

The Position

The Associate Director, Medical Writing (ADMW) is an expert in medical writing, responsible for independently managing and creating critical documents that support clinical development and regulatory submissions. This role involves strategic contributions to development plans, study designs, and regulatory processes while mentoring less-experienced writers and leading key writing initiatives.

You will collaborate with global and local cross-functional teams to ensure timely, high-quality documentation, driving excellence in clinical and regulatory programs.

Key Responsibilities

Document Creation & Strategic Input

Provide strategic contributions to study designs, analysis plans, and development strategies.
Author, review, and edit a variety of regulatory and clinical trial documents, including:
- Clinical summaries, eCTD submissions, INDs, NDAs, and MAAs.
- Investigator brochures (IBs), clinical study protocols, amendments, and reports.
- Regulatory agency submissions, meeting requests, and briefing books.
- Lay summaries, informed consent forms, and pediatric investigational plans.

Collaboration & Leadership

Work with cross-functional teams (Clinical Operations, Biometrics, Regulatory Affairs, etc.) to meet clinical program needs.
Lead discussions on medical writing issues, provide guidance, and facilitate decision-making processes.
Share best practices and optimize medical writing workflows to improve efficiency.

Mentorship & Supervision

Provide mentorship, guidance, and training to less-experienced writers.
Supervise team members as needed and support professional development through Individual Development Plans (IDPs).

Regulatory & Compliance Excellence

Ensure all documents meet ICH-GCP standards, company SOPs, and regulatory requirements.
Stay updated on regulatory guidelines and industry standards to ensure compliance.

Quality & Data Interpretation

Assess document quality and provide constructive feedback.
Interpret and present complex clinical and statistical data clearly and concisely.

Qualifications

Education

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

Experience

9+ years of relevant experience in medical writing for clinical and regulatory documentation.
Extensive experience with global regulatory submissions (FDA, EMA); experience with submissions in Japan or China is a plus.
Strong background in clinical research, drug/device development, and statistical approaches.

Skills & Competencies

Exceptional written and oral communication skills with mastery of English grammar and punctuation.
Proven ability to manage multiple global projects and meet deadlines in a fast-paced environment.
Therapeutic area experience with cell therapies or advanced therapeutics is desired.

Attributes

Strong organizational skills, adaptability, and ability to collaborate across time zones.
Commitment to high ethical standards, accountability, and innovation.

Physical Requirements

Approximately 10% overnight travel, including international travel.

Equal Opportunity Employer

Novo Nordisk is committed to fostering diversity, equity, and inclusion. We provide equal opportunities to all applicants regardless of race, gender, ethnicity, religion, disability, or veteran status.

If you require accommodations to apply, contact us at 1-855-411-5290 (for accommodation requests only).

Apply Now: Novo Nordisk Careers

Together, we’re life-changing.

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Associate Director - Medical Writing

Job Description

Job Title: Associate Director, Medical Writing

About the Department

The Position

Key Responsibilities

Document Creation & Strategic Input

Collaboration & Leadership

Mentorship & Supervision

Regulatory & Compliance Excellence

Quality & Data Interpretation

Qualifications

Education

Experience

Skills & Competencies

Attributes

Physical Requirements

Equal Opportunity Employer

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