Associate Medical Writer Job at Oxford PharmaGenesis (London, Oxford)

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

Associate Technical Writer - Medical Devices

We are seeking an Associate Technical Writer to support the development and main...

Location

Australia , Sydney Bella Vista

Salary:

Not provided

ResMed

Expiration Date

Until further notice

Requirements

2–3 years of experience in a similar role is ideal
Degree in engineering, science, quality, regulatory, or related discipline (or equivalent experience)
Strong attention to detail and organisational skills
Clear written and verbal communication
Ability to follow defined processes and work under guidance
Willingness to learn in a regulated environment

Job Responsibility

Support creation and maintenance of labelling technical documentation
Execute labelling updates using established legacy processes and tools
Create and update content within the Enterprise Labelling System (ELS) under guidance
Perform proofing and quality checks to ensure accuracy, completeness, and compliance to our processes, style guides and brand
Support reviews, approvals, and change management activities

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

Medical Writer

The Medical Writer applies basic to intermediate documentation preparation and d...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree preferred
scientific focus desirable
University-level medical or technical writing course(s) or equivalent experience in science/technical writing
Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association
Up to 2 years as a medical writer in the pharmaceutical industry or at least 5 years of medical or scientific writing experience as a primary job responsibility
Familiar with drug development process (discovery to market)
Basic understanding of biostatistical and clinical research concepts
Basic applied knowledge of documentation required for the conduct of clinical studies, protocol design, study results reporting
Writing high-quality documents that support corporate goals and objectives
Experience writing, reviewing, or editing protocols and clinical study reports preferred

Job Responsibility

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.)
Aids in managing 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
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned

Fulltime

Medical Writer

The Medical Writer 1 applies basic to intermediate documentation preparation and...

Location

United States , San Rafael

Salary:

74100.00 - 100000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree preferred
scientific focus desirable
University-level medical or technical writing course(s) or equivalent experience in science/technical writing
Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association
Up to 2 years as a medical writer in the pharmaceutical industry OR At least 5 years of medical or scientific writing experience as a primary job responsibility
Familiar with drug development process (discovery to market)
Basic understanding of biostatistical and clinical research concepts
Basic applied knowledge of documentation required for the conduct of clinical studies
Basic applied knowledge of protocol design
Basic applied knowledge of study results reporting

Job Responsibility

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.)
Aids in managing 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
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned

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

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 - 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

New

Oncology Scientific Lead, Med Com (Associate Scientific Dir)

Oncology Scientific Lead, Med Com (Associate Scientific Dir). ICON plc is a worl...

Location

United States , Raleigh; Texas; Tennessee; Blue Bell; Boston

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Advanced degree, preferably PhD but PharmD and MD may also be considered
Prior relevant experience in a medical publications/medical communications agency will be a key differentiator for the successful candidate
Minimum of 4–5 years’ experience of high-level content development and management in the medical communication agency setting, with at least 3 years as a Senior Medical Writer, strongly preferred
CMPP™/MAPPS Certification preferred not required
Demonstrable history of relevant high-level writing support and review (e.g, while at a medical communications agency), including proficiency with ICMJE and GPP guidelines
reviewing and interpreting scientific and technical journal content
knowledge of diverse prescribed styles and formats
A demonstrable history and genuine interest in mentoring
People management and client relationship skills preferred
Ability to work efficiently with network directories/databases

Job Responsibility

Oversight and approval of scientific/clinical content for assigned projects/tasks
Function with a greater level of independence on those projects
Review of assigned materials for accuracy and quality
Mentoring and development of junior writing staff
Contributing scientific and therapy area insights
Content oversight and quality control including reviewing of assigned writers’ work
Product/therapy area information and strategic insight
Fact checking assigned manuscripts
Collaboration with the Scientific Manager and account managers to help ensure adherence to agreed-upon timelines
Helping to oversee all aspects of project development from initiation to completion, including financial aspects

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

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Associate Medical Writer

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