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60 Meet Senior Medical Writer Jobs Hiring Near You

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Senior Medical Writer

Blue Bell, PA · On-site +1

Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical ... Collaborate with scientific and account management teams to meet timelines, communicate project ...

Costello Medical

Senior Medical Writer

New York, NY · Hybrid

$90K - $100K/yr

Senior Medical Writers take a leading role across projects, providing strategic advice to clients, supervising the project team, and producing high-quality scientific content themselves. They ensure ...

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Sr Medical Writer

Reading, PA

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

Costello Medical

Senior Medical Writer

Boston, MA · Hybrid

$90K - $100K/yr

Senior Medical Writers take a leading role across projects, providing strategic advice to clients, supervising the project team, and producing high-quality scientific content themselves. They ensure ...

Icon plc

Senior Medical Writer

Blue Bell, PA · On-site +1

Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a ...

Icon plc

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

ICON

Sr Medical Writer

Blue Bell, PA · On-site +1

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

Regeneron Pharmaceuticals

Senior Medical Writer

$128K - $210K/yr

We are seeking a Senior Medical Writer to join our Medical Writing team, supporting clinical document delivery across Global Development in a remote work mode. In this role, you will author clinical ...

Synterex

Senior Medical Writer

Princeton, NJ · On-site

$120K/yr

The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and ...

Argenx

Senior Medical Writer

$104K - $143K/yr

For the expansion of our team, argenx is looking for a Senior Medical Writer who will provide medical writing support for developing complex clinical, nonclinical, and safety documents for regulatory ...

Synterex

Senior Medical Writer

Princeton, NJ · Remote

The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and ...

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Senior Medical Writer

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Boston, MA • On-site

$135K - $180K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 11 days ago

Job description

Description of Role

The Senior Medical Writer will be responsible for authoring and managing clinical regulatory documents in support of the company's clinical development program and objectives. Reporting to the Director, Medical Writing Operations, the Senior Medical Writer's will efficiently prepare high-quality, consistent, and accurate deliverables across the company's development portfolio.

Key Responsibilities

  • Author and provide support for medical writing content, including but not limited to study level documents (clinical protocols and amendments, Investigator Brochures, clinical study reports), agency requests for information, IND/CTA submission documents, NDA/MAA clinical modules and summary documents, and other writing as necessary.
  • Collaborate closely with relevant functions, including Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, CMC, and Project Management teams.
  • Partner with internal and external writers, as necessary, in support of document completion.
  • Oversee document preparation from start to finish, including kick-off activities and planning, drafting, managing review cycles, incorporating feedback and revisions, addressing quality control and quality assurance findings, and providing a final version within document timelines.
  • Ensure clarity, consistency, and proper formatting of clinical documents across programs.
  • Maintain compliance with GCP, ICH, eCTD, and company guidelines.
  • Interpret complex clinical data and information.
  • Demonstrate strategic thinking and review capabilities.
  • Contribute to the development and improvement of SOPs, templates, and document standards.

Qualifications

  • PhD or advanced degree in a scientific or clinical discipline.
  • 4+ years of medical writing or relevant pharmaceutical industry experience, including at least 2 years in sponsor-level clinical/regulatory medical writing.
  • Previous neuroscience experience is strongly preferred.
  • Strong organizational, communication, and influencing skills; ability to prioritize, multitask, and deliver high-quality documents under tight timelines.
  • Flexibility and comfortability with evolving priorities and targets.
  • Understanding of drug development, biostatistics, and medical terminology; basic understanding of scientific methodology as applied to drug development.
  • Knowledge of global clinical trials and regulatory submission requirements (FDA, EMA, PMDA), including ICH, GCP, CTD/eCTD, and EU privacy/redaction regulations.
  • Proficiency in Microsoft Word (advanced features) and familiarity with document management and collaborative authoring platforms (e.g., Veeva Vault, Please Review).
  • Ability to work independently and collaboratively in a dynamic, fast-paced, cross-functional environment.
  • Highly accurate, detail-oriented, and professional, with excellent interpersonal skills and a calm, diplomatic approach to challenges.

Compensation

The annual base salary range for this position is $135,000.00 to $180,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Senior Medical Writer role is based in the US, with occasional travel.

POSITION: Full-Time, Exempt

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