Medical Affairs Medical Writer Job at MillenniumSoft Inc (Sandy, UTAH)

Quality Assurance Specialist, Medical Communications

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experienced Medical Writer (1-2 years)
Scientific background and degree (PharmD, MD, PhD or Masters)
Knowledge of IT and digital solutions
Strong attention to detail and accuracy
Ability to manage and prioritize multiple, detailed activities
Results-orientated with fast and focused execution
Good communication, coordination and time management skills
Ability to work within a team or across multiple teams (including remotely) as well as independently
Fluent in oral and written English with high level of communication skills
Values teamwork, collaboration, and innovation

Job Responsibility

Cross check scientific information against cited references and ensure medical accuracy (fact check)
Ensure consistency with product label where applicable
Verify presence of essential information
Correct interpretation of scientific data from reference/sources
Alignment/formatting of content as per style guides/journal guidelines/congress guidelines
Ensure consistency of scientific content across different sections (including text, figures, tables)
Accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines
Confirm that every sentence is source annotated, and each source annotation matches with respective reference and vice versa
Ensure that information is presented in a neutral manner without any interpretations and/or author’s conclusion
Track work and communicate with client team on job reviews, prioritization etc., through emails and teleconferencing if needed

Scientific Medical Writer

We are seeking a Scientific Writer to serve as a critical bridge between our Res...

Location

Denmark , Københavns Kommune

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

PhD in life sciences, biomedical sciences, pharmacology, immunology, hematology, or related field
Demonstrated experience in scientific writing, including peer-reviewed publications as first author or significant contributor
Strong understanding of clinical drug development processes and regulatory requirements
Excellent written and verbal communication skills with the ability to translate complex scientific concepts for diverse audiences
Meticulous attention to detail and commitment to scientific accuracy
Strong organizational skills and ability to manage multiple projects simultaneously
Proven ability to work collaboratively in a fast-paced, team-oriented environment

Job Responsibility

Lead the preparation of scientific manuscripts for peer-reviewed publications, demonstrating our research and preclinical findings
Lead the preparation of patent filings
Develop and write regulatory documentation including: Technical reports, Investigator's Brochures and briefing documents
Investigational New Drug (IND) applications and Clinical Trial Applications (CTAs)
Regulatory responses and agency communications
Create high-quality abstracts, posters, and presentations for scientific conferences
Collaborate with Medical Affairs to develop scientifically accurate medical communications materials
Prepare scientific brochures, data summaries, and disease-state educational content
Support the creation of materials for advisory boards and key opinion leader (KOL) engagements
Contribute to medical information responses and scientific exchange materials

What we offer

Opportunity to make a meaningful impact on patients living with rare bleeding disorders who have few or no treatment options
Collaborative, mission-driven culture with a commitment to scientific excellence
Work at the forefront of innovation in bleeding disorder therapeutics
Professional development opportunities and growth within a rapidly expanding organization

Fulltime

Senior Medical Writer

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
Excellent writing, editing, and proofreading skills
Ability to communicate scientific concepts to diverse audiences
Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
Experience in interacting with regulatory agencies during the review and approval process
Demonstrated ability to work effectively in a fast-paced, deadline-driven environment, managing multiple projects simultaneously
Excellent interpersonal and communication skills
Ability to collaborate effectively with cross-functional teams, build relationships with key stakeholders, and influence decision-making processes

Job Responsibility

Leading the preparation, review, and editing of clinical study documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and regulatory submissions
Ensuring accuracy, clarity, and compliance with regulatory guidelines and industry standards
Collaborating closely with cross-functional teams, including clinical research, biostatistics, regulatory affairs, and medical affairs, to interpret and analyze clinical trial data, summarize scientific findings, and communicate key insights in written form
Participating in the planning and execution of clinical development programs, providing strategic input and scientific expertise to support the design, conduct, and interpretation of clinical studies and research initiatives
Contributing to the development of publication plans, abstracts, posters, and manuscripts for submission to peer-reviewed journals and presentation at scientific conferences
Mentoring and coaching junior medical writers, providing guidance on best practices, writing techniques, and scientific principles

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

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

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

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

New

Executive Assistant

The Executive Assistant will work 50% as Executive Assistant to the EMEA busines...

Location

United Kingdom , Maidenhead

Salary:

23.59 GBP / Hour

Morson Talent

Expiration Date

Until further notice

Requirements

Minimum 5 years of experience as an Executive Assistant
Degree or certification in office administration or a related field is a plus
Event project management experience is a plus
Excellent knowledge of Microsoft (Outlook, Word, Excel, PowerPoint)
Oracle or similar ERP system experience is a plus
Strong interpersonal skills with a high comfort level in dealing with senior management and individuals at all levels and international backgrounds
Team player who collaborates well across departments to ensure desired outcomes are achieved
Prioritization and time management in a fast paced, high-volume workload, multi-tasking environment while maintaining a high degree of accuracy
Excellent verbal communication, writing and editing skills
Full-time working from Maidenhead, UK

Job Responsibility

Organize, direct, and follow up on all administrative details as assigned, ensuring all work is done accurately and on a timely basis
Administer legal paperwork for business entities, notarize documents and coordinate international postage
Assist in planning of events such as company and department outings, lunch meetings, holiday parties, social committee activities, and offsite meetings
Arrange conference rooms, hotels, catering, dinners, car service, etc. for group meetings
Follow up on ad hoc actions and projects assigned by the business director
Order management
Liaise with customers regarding deliveries
Liaise with the sales team re backlog, orders etc
Stock checks
Raise purchase orders to suppliers

Fulltime

New

Driving Field Agent

Looking for variety in a new and customer facing role? Do you have a passion for...

Location

United Kingdom , Buxton

Salary:

12.55 GBP / Hour

Randstad

Expiration Date

February 14, 2026

Requirements

Valid UK Driving License
Owned Car
Willing to complete a DBS
Willing to obtain business car insurance
Willing to travel up to 40 miles
Excellent verbal communication skills and evidence of persuading reluctant respondents to take part in surveys
Self-disciplined, self-motivated, and happy to work with minimum supervision
Be proficient in the use of laptop and smartphone
Can demonstrate ability to be organised with well-developed planning skills
Proficient in using laptop and smartphone to receive, view and input information

What we offer

0.45p per milage
1 meal per 5 hours (£7.50), 2 meals per 10 hours (£15)

Parttime

Medical Affairs Medical Writer

MillenniumSoft Inc

Location:
United States , Sandy, UTAH

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 11, 2026

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Medical Affairs Medical Writer

MillenniumSoft Inc

Location:United States , Sandy, UTAH

Category:-

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 11, 2026

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Location:
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Job Posted:
January 11, 2026