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

Medical Writer

As a global medtech company, we are driven by our Vision of changing the traject...

Location

United Kingdom , Gloucestershire

Salary:

Not provided

LivaNova

Expiration Date

Until further notice

Requirements

Previous experience in medical writing/reading
Understanding of the impact factor and relevance of scientific journals and papers
Strong skills in data statistics and study design
Industry experience that includes the understanding of Clinical Development, Regulatory Affairs and Marketing activities, through different stages
Understanding of the international guidelines, US and European
Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment
Efficient writing of large documents per project deadlines
Ability to work well with a diverse group of personalities, team player, flexible and adaptable
ability to build relationships, both internally and externally to the organization
Excellent English oral and written (C2)

Job Responsibility

Ensure completion of clinical evaluation plans (CEP) and reports (CER) and Post Market Clinical Follow-up (PMCF) Plans and Reports per each product family within the Cardiac Surgery (CS) franchise in cooperation with all main internal and external stakeholders within the agreed timelines
Perform ad hoc and systematic literature reviews on global scientific newly released data to support Product Market Surveillance reports, Global Signal Detection meetings, Study Design Protocols, Global Market Value Dossiers, Regulatory Dossiers, Medical Affairs scientific summary documents
Provide writing skills to protocols and clinical study reports and all relevant clinical documentation (literature review plans/reports
study protocols/reports
scientific manuscript
congress abstracts/posters/presentations)
Collaborate with cross-functional teams to develop clinical evaluation strategies

Fulltime

Medical Affairs Specialist

MagVenture A/S is expanding and therefore, we are seeking to recruit a colleague...

Location

Denmark , Farum

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Master of Science degree, maybe complemented with a PhD or other types of research/clinical experience
Previous experience as a medical/scientific writer of clinical and regulatory documents, is a plus, but not a requirement
A critical, scientific mindset with a thorough understanding of research methodology, including statistical methods, study design and research concepts
Strong analytical and communication skills
Excellent written and verbal communication skills in both Danish and English
Structured, result-oriented, committed and can handle changes in prioritization of tasks
Thrive in a smaller company where you need to follow projects from one end to the other and contribute to an open and dynamic collaboration with your colleagues, from many different functional areas

Job Responsibility

Drive and maintain Clinical Evaluation Reports (CERs) on our existing portfolio to meet the requirements of the Medical Device Regulation (MDR) and other regulatory bodies
Develop, plan, and write CERs for new indications for use and/or new products
Handle and evaluate Post-Market Information data on an ongoing basis
Write and update Periodic Summary Update Reports (PSUR)
Provide input and support to development projects as well as other regulatory documents, like ‘Instructions for Uses’, usability reports, clinical risk documentation, etc.

What we offer

Flex time
Pension
Canteen
Health insurance
A newly built, super nice office in Farum

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

New

Senior Medical Writer

Are you an experienced Medical Writer looking for a new challenge in medical com...

Location

United Kingdom , Oxford

Salary:

Not provided

Oxford PharmaGenesis

Expiration Date

Until further notice

Requirements

a science PhD, preferably in life sciences
writing experience in the medical communications sector
the ability to deliver high‑quality, accurate and insightful content
confidence when communicating with scientific and healthcare professionals
strategic thinking skills, with the ability to propose innovative solutions
a genuine passion for communicating science
a proactive, collaborative, ‘can‑do’ attitude

Job Responsibility

support rare disease, neurology and oncology projects
work across a wide variety of publication and medical affairs deliverables
broaden scientific experience while contributing to work that is highly valued by clients and colleagues

What we offer

exceptional learning opportunities
empowering and supporting environment
matched charitable fundraising
supporting charities
hybrid working approach
Disability Confident Committed employer

Fulltime

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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Job Description:

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Job Posted:January 11, 2026

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Job Posted:
January 11, 2026