Project Manager

Project Manager at Acumen Medical Communications Project Manager at Acumen Medical Communications in Cambridge, Massachusetts Posted in about 20 hours ago.

Type:

full-time

Job Description:

Acumen is seeking a Project Manager to support the planning and execution of clinical and nonclinical regulatory submissions (INDs, NDAs, BLAs). This role is well suited for an individual with hands-on experience in regulatory operations or medical writing who is looking to expand into project management within a submission-focused environment.

This role supports client projects through coordination, timeline management, operational execution, and team leadership. Scope may vary from leading submission deliverables to supporting targeted initiatives requiring adaptability, ownership, and a willingness to contribute wherever needed. You will anticipate risks, identify gaps, and guide teams through shifting priorities while maintaining structure, clarity, and momentum to deliver high-quality work. Leveraging Acumens technology and standardized tools, this role emphasizes guiding, and advising teams, using systems and automation to support efficient delivery while maintaining focus on decision-making, alignment, and outcomes. Over time, this role offers the opportunity to expand into broader program coordination and contribute to the evolution of project management practices and tools across the organization.

ResponsibilitiesDevelop and actively manage integrated timelines, aligning dependencies, contributors, and key milestones.

Coordinate workflows, roles, and responsibilities across internal teams and client stakeholders.

Partner with client teams to lead or support submission management activities, adapting to program needs.

Track progress against project plans, proactively identifying risks, gaps, and delays.

Facilitate team meetings and drive clear, action-oriented communication.

Coordinate preparation and handoff of deliverables.

Manage day-to-day operational execution across projects, supporting both large-scale submissions and more targeted client initiatives.

Leverage project management tools and systems to streamline workflows. reduce manual effort and maintain real-time visibility into project status.

Demonstrate flexibility and ownership by stepping into a range of project needs, ensuring work progresses efficiently regardless of scope or complexity.

Anticipate and help resolve issues, maintaining momentum and alignment across teamsRequirements~35 years of experience in the biopharmaceutical industry, with direct involvement in regulatory submissions, regulatory operations, or medical writing supportWorking knowledge of regulatory submission processes (INDs, NDAs, BLAs) and familiarity with eCTD structureStrong project management and coordination skills, with experience supporting or leading cross-functional teamsAbility to manage timelines, track dependencies, and coordinate multiple workstreams in a structured environmentExcellent communication and interpersonal skills, with the ability to work effectively with both internal teams and client stakeholdersTech-savvy, with comfort using project management and collaboration tools; experience with Point and Microsoft Office required, and Smartsheet strongly preferredStrong organizational skills and attention to detail, with the ability to manage both high-level timelines and day-to-day executionAdaptable and proactive, with a willingness to take ownership across a range of project needs and levels of complexityAcumen is committed to employing and developing well-rounded publications and medical affairs professionals. Ours is a culture of sharing knowledge and expertise and provides opportunities for cross-functional training within the medical writing and medical affairs landscape.

BCBS Medical, Dental & Vision (80% employer-paid) 401(k) with immediate vesting and a 100% match on the first 4% of employee deferrals

Generous PTO:

Vacation, sick and holidayFully remote work environment with flexible schedulingProfessional development opportunities across medical writing, regulatory communications, and advanced software toolsUS residents only recblid rtufnb78ouizpd5xxqvoh9ag6dps69