Senior Medical Writer Job at Product Life Group

Senior Medical Writer

Our client, a NYC-based pharmaceutical agency, is seeking experienced Freelance ...

Location

United States , New York

Salary:

60.00 - 70.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

Prior agency experience as a medical writer in a med comms, promotional, or publications agency environment
Experience with scientific writing, referencing, and annotation of clinical content
Familiarity with Medical-Legal-Regulatory (MLR) review processes
Proven ability to interpret, review, and summarize peer-reviewed medical literature
Strong attention to detail with the ability to manage deadlines in a fast-paced environment

Job Responsibility

Develop, edit, and review high-quality medical and scientific content for pharmaceutical and healthcare communications
Annotate, cite, and reference scientific and clinical source materials accurately and consistently
Conduct literature reviews and synthesize findings from peer-reviewed medical journals
Support Medical-Legal-Regulatory (MLR) review processes, including addressing reviewer feedback and ensuring compliance
Collaborate closely with cross-functional teams including account, strategy, creative, and medical affairs
Ensure all deliverables meet scientific accuracy, regulatory requirements, and brand guidelines

What we offer

Medical
Dental
401(k)
Direct deposit
Commuter benefits

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

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

Location

United States

Salary:

142100.00 - 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 (eligibility may vary based on role)
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
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, 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

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

Associate Director Medical Writer

The Associate Director Medical Writer is an individual expert who can manage and...

Location

Canada , Mississauga

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

PhD or relevant working experience within the life sciences space
Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide
Demonstrated effectiveness in management of projects of increasing scope and complexity
Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions
High-level computer skills and general computer literacy
Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents

Job Responsibility

Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines
Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
Provide major input to submission teams in development of submission plans, timelines, document content and dependencies
Advises on or recommends methods for achieving accelerated timelines, including review tools and automation
Actively contribute to development of training materials for clinical document preparation
provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
Effectively contribute to process improvement activities

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

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