Manager, Medical Writing

Prometrika LLC•Cambridge, MA

About The Position

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We’re driven by our passion for the human aspect of our work and our compassion for the people whose lives have been improved by the innovations we help bring to market. Our clients include national and international biopharmaceutical and medical device companies of all sizes. The Manager, Medical Writing position is responsible for overseeing and participating in the development of high-quality clinical and regulatory documents in support of global drug development programs of PROMETRIKA’s sponsors. This role requires writing and editing of protocols and scientific and clinical reports including summaries from statistical analyses for submission to regulatory agencies or sponsor use, comprehensive literature reviews, abstracts, posters, and other projects requiring skill in written communication. The Manager, Medical Writing will also contribute to departmental leadership, training initiatives, business development efforts and organizational thought leadership:

Requirements

Bachelor’s Degree in Science is required
A minimum of 10 years experience in biotechnology/pharmaceutical industry
A minimum of 7 years regulatory writing in biotechnology/ pharmaceutical industry
Previous experience in developing clinical and regulatory documents, such as protocols, CSRs, IBs, INDs, ISS/ISE, and DSURs. Previous involvement in writing at least one NDA/BLA/ MAA is required
Knowledge of ICH /GCP, FDA, EMA and other regulatory guidance for clinical and regulatory submissions
Strong command of scientific and medical terminology with the ability to translate complex information into clear, accurate, and regulatory-compliant content
Excellent written and verbal communication skills, with attention to detail and quality
Ability to manage multiple projects and competing priorities in a fast-paced environment
Knowledge of electronic document platforms is desired

Nice To Haves

MS or a Ph.D. is preferred
Experience managing medical writers or contractors preferred
Previous experience working in a clincial research organization (CRO) is strongly preferred
Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred

Responsibilities

Manage and supervise junior medical writers and/or external contractors
Oversee and/or participate in the development/writing of:
Clinical Development Plans (CDPs)
Clinical study protocols and Clinical Study Reports (CSRs)
Coordinating and integrating writing of other document sections provided by the project statistician, medical monitor, and other team members
Clinical sections of INDs, NDAs/BLAs and MAAs and other submission documents (e.g., ISS/ISE, Clinical Summaries)
Initial and or updates for Investigator Brochures (IBs) and IMPDs
Annual reports and DSURs
Briefing documents for regulatory submissions
Journal articles, abstracts, and posters in cooperation with statisticical leads
Ensure documents meet company, client, and regulatory standards, including ICH/GCP guidelines
Oversee multiple projects simultaneously, ensuring timelines and deliverables are met
Conduct document review meetings to discuss comments/ edits by PROMETRIKA Team and/ or Sponsor
Provide cross-functional medical writing support
Attend client meetings as required
Assist with tracking and reporting significant changes in scope of work and recommending change of scope orders to management, when appropriate
Perform other duties as assigned
Develop and update on an ongoing basis medical writing SOPs and training manuals
Develop and lead Medical Writing departmental initiatives aligned with organizational strategic goals
Uphold, demonstrate and teach junior team members PROMETRIKA’s Core Competencies
Develop internal training materials and deliver trainings as in support of PROMETRIKA Technical Training Committee initiatives
Recruit, develop, mentor and supervise team members as appropriate to meet the service obligations of the department
Contribute materials and present at internal Lunch and Learns to cross-train and share Medical Writing expertise within our organization
Proactively contribute to PROMETRIKA’s newsletters, thought leadership blogs, and other publications as appropriate
Collaborate with Client Relations to participate in Medical Writing at bid defense meetings
Partner with Client Relations on efficient and timely completion of Requests for Information (RFIs) and Requests for Proposals (RFPs)