Manager, Medical Writing

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.

RESPONSIBILITIESThe 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 statistical 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 clinical 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.