Medical Writing Operations Manager Job at Proclinical (Cambridge)

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Manager, Clinical Operations, International

Cabaletta is seeking a Manager/Sr Manager, Clinical Operations, International. R...

Location

Germany; Switzerland

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s Degree or advanced degree in life sciences or related field
Minimum 4 years of clinical trial management experience including management of study resources, vendors, budgets, supplies, critical path activities, and risk management, within Biotech or pharmaceutical industry or equivalent by experience
Cell therapy experience preferred and/or focus complex therapies
Fluency in English
working proficiency in additional European languages a plus
Experience with early phase, complex trials
Experience managing Contract Research Organizations and other external vendors
Good understanding of European regulatory requirements (EMA, MHRA, etc)
Working knowledge of GCP/ ICH regulatory guidelines
Extensive knowledge of standard industry practices related to study start-up, site management and monitoring, document management, and clinical supply management

Job Responsibility

Provide day-to-day clinical project management oversight of the full range of clinical operations activities associated with clinical trial conduct from protocol development, feasibility/capability assessments, initiation, execution, control, and closure
Perform hands-on activities not outsourced to vendors, as needed
Author study documents and plans such as ICF and study specific plans
Provide input and review of site training materials
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Proactively identify risks and lead team members to mitigate risks in a timely fashion
Develop and maintain positive relationships, both internal and external to project, including site personnel (KOLs, PIs, Study Coordinators)
Select and manage vendors
Perform and document study-level Sponsor Oversight of outsourced clinical activities
Execute clinical operations country submission tasks and documents: Review submission pack, coordinate country-specific ethics RFIs, review and update site-specific consent forms

What we offer

health and retirement
PTO
stock option plans

Senior / Principal Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Excellent interpersonal, negotiation, verbal, and written communication skills
A flexible attitude with respect to work assignments and new learning
Motivation to work consistently in a fast-paced, rapidly changing environment
Ability to manage multiple / varied tasks with enthusiasm and prioritize workload with attention to detail
Competent working in a matrix environment and values the importance of teamwork
Possesses team leadership skills and cross-cultural sensitivity
Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate
Presents solutions and follows through to ensure problems have been satisfactorily resolved
Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Manage ongoing and/or revised project documentation and correspondence
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission
Project Management: Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents
Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project
Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences
Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence
Client Liaison/Service: Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management

What we offer

Structured career pathway and encouragement to develop within the role including awareness and understanding of the industry
Competitive base salary
Holiday
Private healthcare
Other benefits that you would expect with a top company in the CRO Industry

Medical Writer

The Medical Writer position with PrimeVigilance offers an opportunity to further...

Location

United Kingdom , Guildford

Salary:

Not provided

PrimeVigilance

Expiration Date

Until further notice

Requirements

PhD or MSc in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicine)
Previous experience of drug safety medical writing, including PBRERs, DSURs, RMPs
Time management, organisation and multitasking skills with good attention to detail
Strong communication and presentation skills
Advanced knowledge of MS Office
Fluency in English

Job Responsibility

Author Medical Writing tasks including aggregate reports, RMPs and other documents needed throughout the product’s life cycle
Responsible for the quality and content of the document, and quality control review of documents prepared by Medical Writing peers
Continuous self-education in all aspects associated with Medical Writing activities
Active participation in trainings, maintenance, and development of quality system documents
Support in all PV operations associated with Medical Writing

Director, Medical Writing Lead

The Director, Medical Writing is accountable for medical writing deliverables of...

Location

Italy , Milano

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Undergraduate degree and at least 13 years of relevant experience in medical writing, the pharmaceutical industry, and/or clinical research
Advanced scientific degree and at least 10 years of relevant experience
Deep expertise in global regulatory submissions, including IND/CTA and NDA/MAA preparation, document strategy, and lifecycle management
Proven experience leading document strategies and submission activities across one or more development programs
Experience across diverse organizational settings (pharma, biotech, and CRO) is preferred
Advanced knowledge of global regulatory standards
Strong leadership and people management capabilities
Ability to manage multiple complex projects under tight timelines
Exceptional communication and influencing skills
Demonstrated expertise in outsourcing and resource management

Job Responsibility

Lead team of medical writers on best practices in medical writing and regulatory submission processes
Contribute to design of new operating model for medical writing
Work closely with the reg digital team to explore and assess new technologies such as generative AI and automation
Accountable for the successful planning and implementation of all clinical and regulatory written components of global regulatory submissions across one or more development programs
Provide overall oversight, review, and approve study-level documentation required for clinical trials, submission documents and other reports intended for regulatory interactions
Execute cross-functional process improvement initiatives on document standards, template development, and document processes
Facilitate systems and best-practices for training multidisciplinary colleagues participating in document authorship
Provide oversight for the quality and compliance of written components to company standards as well as regulatory requirements through oversight of the clinical quality control function
Collaborate with clinical and regulatory teams to establish optimal interfaces to enable efficient and thorough authorship/revision of key technical documents and oversight of diverse regulatory submission documents to support regulatory filings
Partner with other cross-functional leadership to ensure rapid identification of risks, issues, and development of potential solutions to maintain filing timelines and quality

What we offer

Be part of a growing, innovation-driven company entering new therapeutic areas
Work on global, high-impact projects shaping access to cutting-edge specialty medicines
Collaborate with a diverse team of scientific and commercial experts
Enjoy a high level of autonomy and strategic influence within a global organization
Opportunities for career growth, international exposure, and leadership development

Senior Manager, Clinical Data Management

The Senior Manager is responsible for independently leading multiple, high volum...

Location

United States , Newton

Salary:

Not provided

Beacon Hill

Expiration Date

Until further notice

Requirements

10-12+ years of experience
Experience in Oncology
Experience in Medidata Rave
Experience in elluminate preferred

Job Responsibility

Effective in identifying potential Out of Scope activities prior to vendor beginning work, modify/update study contracts while staying within budget, with guidance by a Director of CDM as needed
Provide leadership and direction to junior staff and peers, by mentoring, training and guiding a study team to meet study deliverables within the ICH/GCP guidance
Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports and input from project team members
Ability to recognize, evaluate and develop plans to mitigate risk as needed from study initiation to study close-out
Perform all aspects of Clinical Data Management as related to processing and QC of the data, monitor study status, (e.g. Enrollment, eCRFs, Query Aging, etc.) and provide status reports to the team and Director CDM throughout the study
Work in conjunction with external vendors, CRO(s), CDM Team, Clinical Team to Review/Create (electronic) Case Report Forms and annotated Case Report Forms per Protocol for assigned study (s)
Co-create and review DM SOPs and Work Instructions in accordance with current GCP and ICH guidelines
Review eCRF completion guidelines, data management plan (DMP), data validation specifications (DVS, e.g. edit checks), SAE Reconciliation Plan, Data Cleaning Plan and other DM related documentation in conjunction with CRO(s), providing feedback and guidance where necessary
Assist CRO(s) with cleaning data for Interim Analysis, Database lock, and any ad hoc requests
Liaise with external vendors (Central Labs) in support of timelines and data related deliverables

Fulltime

Quality Production Operations

Join the Quality Production Operations team to drive excellence in manufacturing...

Location

Italy , Rome

Salary:

Not provided

Cosmo Intelligent Medical Devices

Expiration Date

Until further notice

Requirements

Knowledge of 2017/745(MDR) and 21 CFR 820
Knowledge of 13485: 2021
Strong technical troubleshooting and problem-solving skills
Excellent communication and collaboration abilities
Good English Level (writing and speaking)
Ability to work independently and collaboratively across multifunctional teams
Resilient and able to work effectively under stress and tight deadlines
Willingness to travel as needed
Minimum of 2 years of experience in the quality assurance role within the medical devices or healthcare industry, with a strong focus on production processes
Bachelor’s degree in engineering, or a related field

Job Responsibility

Oversee all processes related to the collection and review of the production records
Review the Device History Records related to medical device products and ensure the correctly storage of records
Support the Medical Device Production Manager in the planning of the production process
Ensure that all production activities comply with regulatory standards, quality control protocols, and company policies
Incoming Inspection: support the R&D ensure that the procedure for deciding when the lot under inspection is to be rejected or accepted
Equipment Management: manage the equipment calibration and archive the records
Non conformities management: open and manage the non conformities issued during the production process, correction and corrective action
Problem Solving: support the Medical Device Production Manager in the implementation of the corrective actions to minimize disruptions and maintain continuous production flow. Ensure that activities are correctly carried out and registered
Supplier Management: perform the supplier qualification and supplier monitoring process and support the Quality Assurance Manager during the audit at the supplier
Training: ensure that the training and guidance to production staff are correctly registered

Senior Medical Writer - FSP

As a Medical Writer at Parexel, your strong scientific knowledge, writing skills...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP
Extensive clinical/scientific writing skills
Scientific background essential
writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar
Advanced word processing skills, including MS Office (expertise in Word)
software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel)
Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation
Excellent interpersonal, verbal, and written communication skills
Ability to consistently produce documents of high quality

Job Responsibility

Author Clinical Documents: Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy
Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input
Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable
Perform literature searches/reviews as necessary to obtain background information and training for development of documents
Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing
Quality Control: Ensure that all work is complete and of high quality prior to team distribution or shipment to client
Confirm data consistency and integrity across the document
Prepare documents for publishing readiness, when applicable
Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable
Provide suggested alternative content when contributors provide content that does not meet document needs

What we offer

Foster a culture of inclusivity, collaboration, and support
Continuous learning from being mentored to job shadowing, job rotation, and stretch assignments, as well as becoming a mentor or leading a team
Development and promotion based on global standards and your personal development plan
Supportive and inclusive environment
Career growth and development
Mentorship
Flexible work
Diverse projects
Culture of excellence
Global exposure

Medical Writing Operations Manager

Proclinical

Location:
United States , Cambridge

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 07, 2026

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