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Prometrika Llc Jobs (NOW HIRING)

Prometrika LLC

Manager, Medical Writing

Cambridge, MA · On-site

$136K - $164K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Prometrika LLC

Senior Medical Writer

Cambridge, MA · On-site

$134K - $162K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Prometrika LLC

Senior Clinical Data Manager

Cambridge, MA · On-site

$144K - $167K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Prometrika LLC

Clinical Trial Manager

Cambridge, MA · On-site

$140K - $168K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Prometrika LLC

Principal Biostatistician

Cambridge, MA · On-site

$178K - $216K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Prometrika LLC

Clinical Trial Associate I

Cambridge, MA · On-site

$60K - $75K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

Prometrika LLC

Clinical Trial Associate II

Cambridge, MA · On-site

$75K - $90K/yr

PROMETRIKA is a full-service clinical research organization (CRO) with extensive experience in clinical operations, data management, biostatistics, medical writing, and pharmacovigilance. We're ...

All JobsPrometrika Llc Jobs

Prometrika Llc information

What types of projects do clinical research professionals typically work on at Prometrika LLC, and how does this impact day-to-day responsibilities?

At Prometrika LLC, clinical research professionals are often involved in a variety of projects ranging from early-phase clinical trials to late-stage studies across multiple therapeutic areas. This diversity means that day-to-day responsibilities can include protocol development, data management, regulatory submissions, and close collaboration with cross-functional teams such as biostatistics and medical writing. The dynamic project environment encourages professionals to be adaptable and proactive, while offering the opportunity to develop a broad skill set and work closely with sponsors and investigators.

What are the key skills and qualifications needed to thrive as a Clinical Research Associate at Prometrika LLC, and why are they important?

To excel as a Clinical Research Associate at Prometrika LLC, you typically need a background in life sciences or a related field, along with clinical research experience and knowledge of Good Clinical Practice (GCP) guidelines. Familiarity with electronic data capture (EDC) systems, regulatory documentation, and trial management software is important. Strong attention to detail, organizational skills, and clear communication are vital soft skills for effectively coordinating studies and collaborating with research teams. These competencies ensure compliance, data integrity, and successful execution of clinical trials.

What is the difference between Prometrika Llc vs Data Analyst?

AspectPrometrika LlcData Analyst
Required CredentialsBachelor's degree in related field, relevant certificationsBachelor's degree in statistics, mathematics, or related field; certifications like CAP or Microsoft Certified Data Analyst
Work EnvironmentOffice-based, collaborative team setting, healthcare or marketing industriesOffice or remote, data-focused environment across various industries
Employer & Industry UsageHealthcare analytics, marketing research, consulting firmsBusiness, finance, healthcare, technology sectors

Prometrika Llc and Data Analyst roles often require similar educational backgrounds and certifications. While Prometrika Llc may focus on healthcare or marketing analytics, Data Analysts work across diverse industries. Both roles involve data collection, analysis, and reporting, but Prometrika Llc may have more industry-specific tools and client-focused projects.

What is Prometrika LLC and what services do they provide?

Prometrika LLC is a full-service clinical research organization (CRO) that offers support to pharmaceutical, biotechnology, and medical device companies. They specialize in clinical trial management, data management, biostatistics, regulatory affairs, medical writing, and pharmacovigilance. Prometrika helps sponsors bring their products to market by managing and executing clinical studies from early-phase through post-marketing. Their team provides expertise in complex study designs, regulatory compliance, and project management to ensure high-quality research outcomes.
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Prometrika Llc jobs near you
Manager, Medical Writing

Manager, Medical Writing

Prometrika LLC

Cambridge, MA • On-site

$136K - $164K/yr

Full-time

Posted 28 days ago

Job description

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.


RESPONSIBILITIES

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:

Medical Writing

  • 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


Departmental responsibilities

  • 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

Thought Leadership

  • 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


Business Development Support

  • 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)

EDUCATION

  • Bachelor’s Degree in Science is required
  • MS or a Ph.D. is preferred


EXPERIENCE

  • A minimum of 10 years experience in biotechnology/pharmaceutical industry
  • A minimum of 7 years regulatory writing in biotechnology/ pharmaceutical industry
  • Experience managing medical writers or contractors preferred
  • 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
  • Previous experience working in a clincial research organization (CRO) is strongly preferred


SKILLS

  • 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
  • Additional knowledge/experience in other aspects of drug development (e.g., clinical trial monitoring, data management, statistics) is preferred


Physical Requirements

Incumbents generally must be able to, with or without accommodation, have the proficient use of both sensory perception/clarity and muscle control/coordination. This may include vision (near, far, color, glare control), hearing (auditory attention, sound localization), speech, strength, agility, dexterity flexibility, steadiness or reaction time.


The salary range for this position here noted is representative of a good faith estimate of all experience levels for this position. PROMETRIKA considers several factors when extending and offer, including but not limited to the role, the function and associated responsibilities, the candidate’s work experience, education/training background and parity with current employees in the same or similar positions.