Medical Writing Manager Job at Randstad (東京23区)

Sr Manager Medical Writing

Help bring science to life and join a leading pharmaceutical company to play a k...

Location

France , Paris

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Background in Life Sciences or related discipline
advanced degree preferred
Expertise in medical writing within pharmaceutical or CRO environments
Experience leading regulatory writing for major submissions (e.g., marketing applications)
Strong understanding of ICH guidelines, GCP, and global regulatory requirements
Proven ability to manage teams and external vendors in a matrixed or global setting
Excellent leadership, organizational, and time-management skills
High standards for data integrity, quality, and compliance
Professional medical writing certification or training is advantageous
Fluent in English, both written and verbal

Job Responsibility

Define and implement medical writing strategies across multiple clinical programs
Collaborate with Regulatory Affairs, Clinical Development, and Safety teams to align submission planning and timelines
Oversee, mentor, and develop medical writing team members and project leads
Oversee outsourced medical writing activities, ensuring quality and timely delivery
Author and review clinical and regulatory documents, ensuring adherence to internal standards and regulatory requirements
Manage multiple projects, balancing timelines, scope, and resources effectively
Contribute to process improvement initiatives, including the development of tools, templates, and workflows
Communicate complex scientific information clearly to diverse audiences and provide constructive feedback to team members
Promote compliance with health, safety, and environmental requirements, ensuring adherence to internal procedures

Fulltime

Medical Writing Operations Manager

Be the backbone of innovation and join a leading pharmaceutical company to help ...

Location

United States , Cambridge

Salary:

70.00 - 77.00 USD / Hour

Proclinical

Expiration Date

Until further notice

Requirements

Background in a relevant scientific or technical field, or equivalent experience
Experience in document QC and electronic publishing within a regulatory environment
Strong understanding of health authority, ICH, PDF, and eCTD requirements
Familiarity with electronic document management systems
Proven ability to manage multiple projects in a fast-paced, deadline-driven environment
Detail-oriented with strong analytical, problem-solving, and adaptability skills
Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat, and Windows

Job Responsibility

Collaborate across teams to collect, compile, and publish Clinical Study Report (CSR) appendices
Perform quality control (QC) checks on electronic publishing, including hyperlinks and bookmarks, to meet submission guidelines
Format MS Word documents according to style and regulatory requirements, troubleshooting formatting issues as needed
Act as a subject matter expert (SME) for format QC, submission readiness protocols, Investigator Brochures (IBs), CSRs, and document management systems
Ensure proper storage and archiving of documents in electronic document management systems (EDMS) and electronic trial master file (eTMF) systems
Conduct content QC for medical writing documents, such as CSRs, IBs, clinical sections of NDAs/MAAs, and protocols
Support the creation, maintenance, and updates of templates, style guides, and tools to align with global regulatory requirements
Perform administrative tasks to support projects and operational needs
Contribute to the development and maintenance of internal best practices
Assist in the implementation and upkeep of medical writing systems and software

Global Regulatory Writing Manager

To author and gain approval of scientific and regulatory submission documents th...

Location

Japan , Tokyo

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master’s degree and 3 years of directly related experience
OR Bachelor’s degree and 5 years of directly related experience
OR Associate’s degree and 10 years of directly related experience
OR High school diploma / GED and 12 years of directly related experience
Ability to analyze scientific data and interpret its significance in practical applications, with limited oversight
Excellent written/oral communication skills and attention to detail in local native language
Upper-intermediate level business English (capable of communicating appropriately in most situations, equivalent to TOEIC score of 730+
Highly skilled word processing and other Microsoft Office Programs
Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds

Job Responsibility

Author regulatory submission documents, as assigned, including Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and other regulatory documents according to the local needs
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With considerable supervision, manage regulatory writing activities for local product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on local product teams - May provide functional area input for Local Regulatory Plan and team goals
Work with CRO and freelance writers
Participate in departmental and cross-departmental initiatives as appropriate
May participate in training and mentoring of junior regulatory writers
May participate in departmental and cross-departmental initiatives, as appropriate
Generate document timelines, with team input
Keep abreast of relevant professional information and technology

Flow manager medical assistant

Responsible for assisting the physician and/or Advanced Care Practitioner (ACP) ...

Location

United States , Charlotte

Salary:

22.90 - 34.35 USD / Hour

Advocate Health Care

Expiration Date

Until further notice

Requirements

High school graduate or equivalent required
Current American Heart Association (AHA) BLS certification required. Must maintain current certification
Must possess one of the following: a) Completion of an accredited Medical Assistant program
b) Intermediate EMT or Paramedic Program with 3 years prior clinical experience required
c) Structured military training which is clinical in nature per DD214
d) Graduate of an Accredited School of Professional Nursing
e) 3 years on the job training and successful completion of CHS Medical Group approved competency assessment
Recognized/certified as a CMA or RMA by one of the following National Organizations: American Association of Medical Assistants (AAMA)
National HealthCareer Association (NHA)
National Healthcare Worker's Association (NHCWA)

Job Responsibility

Responsible for assisting the physician and/or Advanced Care Practitioner (ACP) with patient care, patient intake at office visit, documentation, vaccine and medication administration, clerical, environmental, and organizational tasks
Assists with appointment scheduling and maintaining medical record
Demonstrates the knowledge and skills necessary to provide care for newborn, pediatric, adolescent, adult, and/or geriatric population of patients, as pertinent to the scope of the specialty of the office setting
Pre-visit planning with provider and care team
Follows the patient intake/rooming work in place at the practice
May include medication administration, including injections
Check vital signs, height, and weight
May assist with reviewing medication history and updating medication list
May assist with satisfaction of pertinent health maintenance requirements
Point of Care testing (POCT) per standing order or provider order

What we offer

Sign-on Bonus eligible
robust benefits package
paid time off
opportunities for career advancement
Premium pay such as shift, on call, and more based on a teammate's job
Incentive pay for select positions
Opportunity for annual increases based on performance
Paid Time Off programs
Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
Flexible Spending Accounts for eligible health care and dependent care expenses

Fulltime

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

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Global Regulatory Writing – Senior Manager

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master’s degree and 6 years of directly related experience OR Bachelor’s degree and 8 years of directly related experience OR Associate’s degree and 10 years of directly related experience OR High school diploma / GED and 12 years of directly related experience
Ability to independently analyze scientific data and interpret its significance in practical applications
Excellent written/oral communication skills and attention to detail
Highly skilled in word processing and other Microsoft Office programs
Expertise in scientific/technical writing and editing, and of overall clinical development process for new compounds
Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
Ability to understand, follow, and develop complex standard operating procedures (SOP’s), guidance documents, and work instructions
Excellent time and project management skills
Self-starter with a drive and perseverance to achieve results and motivate others

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, Pediatric Investigation Plans, and other regulatory documents
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
Oversee the work of contract and freelance writers train, mentor, or supervise more junior medical writers, as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timeline and keep abreast of relevant professional information and technology

Fulltime

Senior Medical Information Manager

SRG are partnered with a leading Global Pharmaceutical Company who have an oppor...

Location

Ireland , Dublin

Salary:

33.00 - 38.00 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

Life sciences degree and/or postgraduate qualification
Significant experience within Medical Information (ideally including above country level experience)
Strong knowledge and application of good practices in medical enquiry management and writing for medical information
Experience with reviewing medical/clinical content and providing constructive feedback
Strong cross-functional skills and proven experience in collaboration with other departments/groups

Job Responsibility

Handle Medical Information (MI) enquiries in an efficient and appropriate manner
Collaborate with the MI function in the affiliate countries to ensure consistency and alignment in communication
Provide product related, clinical guidance to sales & marketing teams
Supporting Medical Information activities at congresses
Developing content for digital platforms

Fulltime

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Medical Writing Manager

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