Senior Medical Writer Job at BioMarin Pharmaceutical

Senior Medical Writer

Location

France

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Pharmacist or physician residing and operating in France
Minimum 5-8 years of experience in a PV department (preferentially in a Medical Writing department)
Well versed with Safety databases

Job Responsibility

Analysis of data and preparation of ad hoc reports/plans in the framework: PADER
Risk management plan
Benefit / risk evaluation report
Signal detection and reporting
PSUR / PBRER / Addendum to Clinical Overview
DSUR
Off label use reports (French requirements)
PSUSA response
Literature screening for medical writing reports
Ad hoc reports from regulatory authority

Fulltime

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

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
Ability to manage multiple projects simultaneously and prioritize tasks based on project timelines and deliverables
Excellent interpersonal and communication skills

Job Responsibility

Deliver high quality relevant Clinical Pharmacology & Pharmacometrics (CPP) documents (e.g. population PK/PD data transfer plans, population PK/PD analysis plans and population PK/PD reports), as well as CSRs, protocols, and other documents, within the required regulatory system per global aligned procedures of the client
Write clear and concise documents, including study reports, protocols, investigator brochures, summary documents, and other scientific documents
Drive the document preparation process, receive and review primary statistical output, draft and distribute documents for review, and incorporate/resolve comments with all reviewers
Provide scientific and medical writing consultancy to project teams, as requested
Services rendered will adhere to applicable client’s SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
Ensure clear communication with clinical pharmacology & pharmacometric leaders and other team members
Ensure deliverables are inspection ready and compliant with relevant requirements
Maintain the central planning of population PK/PD document writing and QC deliverables

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 to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and documen...

Location

United States , San Rafael

Salary:

116000.00 - 159500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility
Experience writing, reviewing, or editing protocols and clinical study reports required
Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
Experience writing, reviewing, or editing regulatory briefing books preferred
Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced applied knowledge of basic clinical laboratory tests
Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection

Job Responsibility

Applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams)
Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

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

Senior Medical Writer

Oxford PharmaGenesis is looking for a talented Senior Medical Writer to join one...

Location

United Kingdom , Oxford

Salary:

Not provided

Oxford PharmaGenesis

Expiration Date

Until further notice

Requirements

a science degree (PhD advantageous), preferably in life sciences
writing experience in medical communications
experience in metabolic disease (desirable, not essential)
the ability to develop high-quality content
demonstrable leadership skills, with the ability to work across multiple different deliverables
experience of developing strong client relationships and driving organic growth

Job Responsibility

design and deliver innovative publications within metabolic disease with opportunities to work on other scientific communications
help business development opportunities across the team’s diverse accounts
lead on projects and mentor junior writers

What we offer

exceptional learning opportunities
matched charitable fundraising
support for charities
hybrid working approach
Disability Confident Committed employer

Fulltime

Senior Medical Writer

The Senior Medical Writer: 1) writes original content for publications activitie...

Location

United States , West Chester

Salary:

Not provided

Synchrony Group

Expiration Date

Until further notice

Requirements

PhD, PharmD, or MD
Minimum of 3 years’ experience in medical communications
Substantial professional medical writing experience in a wide variety of communication formats
Ability to work independently on assigned projects
Excellent attention to detail and high degree of scientific and medical accuracy
Ability to manage outcomes to win-win resolution
Ability to identify key issues and to creatively and strategically overcome challenges or obstacles
High level of integrity, ethics, confidentiality, and accountability
Sound analytical thinking, planning, prioritization, and execution skills with an ability to multitask
Well-developed professional communication skills, including written and interpersonal

Job Responsibility

Demonstrate a command of assigned therapeutic areas and expertise with assigned products
Write original content for publication/communication activities (primary and review manuscripts, abstracts, posters), slide presentations, meeting summaries, and other materials for HCP and internal audiences
Prepare materials according to internal writing guidelines and other applicable guidelines (eg, client-specific style guidelines, compliance best practices, journal style guidelines)
Follow all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices, including GPP3
Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed
Interpret and apply clinical data
Maintain a proactive approach on initiatives for existing and prospective clients
Work in conjunction with team members to manage workload and develop and adhere to logical and attainable timelines for project completion
Attend team meetings to provide input and aid in troubleshooting/problem-solving
Efficiently and accurately collate and incorporate author/client comments

What we offer

Competitive salaries
Generous paid time off
Excellent health insurance
Family leave
401(k) plan with employer matching

Fulltime

Senior Medical Writer, Patient Safety

ABOUT THIS ROLE Key Accountabilities: Note: The below statements describe the ...

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Prior experience in pharmacovigilance, or related fields is preferred
Demonstrates Solid understanding of global pharmacovigilance regulations, medical terminology, and safety-related concepts

Job Responsibility

Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions
Develops strategic approaches for challenging safety submissions
Reviews and approves high-complexity safety documents
Coordinates multi-document submissions
Provides expert guidance on evolving global regulatory requirements
Manages meeting logistics
Designs and implements advanced signal detection plans
Leads signal detection for priority products
Develops robust literature review strategies
Authors and reviews high-priority signal assessment reports

Fulltime

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