(Contract) CMC Writer

(Contract) CMC Writer at Acumen Medical Communications (Contract) CMC Writer at Acumen Medical Communications in Cambridge, Massachusetts Posted in 8 days ago.

Type:

contract

Job Description:

Acumen is seeking an experienced (Contract) CMC Writer to support client submission teams on a project-by-project basis. This individual will lead the development of CMC content for INDs and nonclinical components of NDAs and BLAs, with a focus on eCTD Modules 2 and 3.This role is highly collaborative and will work closely with Acumen writers, program managers, editors, publishers, and client stakeholders to deliver submission-ready documents that meet the highest standards of quality and compliance.

Core Responsibilities:

Lead authorship of CMC portions within Modules 2 and 3Work within Acumen and client eCTD templates to ensure consistency and submission readinessPartner with client SMEs to shape content, structure, and key messagingDraft and refine documents through all stages, including comment resolution and leading review discussionsDevelop and manage document timelines aligned with broader submission plansApply deep knowledge of ICH, FDA, and global regulatory guidance to ensure compliance and scientific rigorCollaborate cross-functionally to deliver clear, accurate, and polished documents

Qualifications:

Advanced degree (PhD, PharmD, MS, or equivalent) in a relevant scientific disciplineDemonstrated experience in CMC regulatory writingProven track record contributing to eCTD Modules 2 and 3Experience supporting IND, NDA, and/or BLA submissionsAbility to translate complex data into clear, concise, submission-ready contentStrong organizational skills with the ability to manage timelines and multiple stakeholdersExperience with biologics is a plus recblid xwjfsj751wn6g5vpfoe84serxb9vui