Associate Medical Writer Job at EMJ (London)

Medical Writer

The Medical Writer position with PrimeVigilance offers an opportunity to further...

Location

United Kingdom , Guildford

Salary:

Not provided

PrimeVigilance

Expiration Date

Until further notice

Requirements

PhD or MSc in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicine)
Previous experience of drug safety medical writing, including PBRERs, DSURs, RMPs
Time management, organisation and multitasking skills with good attention to detail
Strong communication and presentation skills
Advanced knowledge of MS Office
Fluency in English

Job Responsibility

Author Medical Writing tasks including aggregate reports, RMPs and other documents needed throughout the product’s life cycle
Responsible for the quality and content of the document, and quality control review of documents prepared by Medical Writing peers
Continuous self-education in all aspects associated with Medical Writing activities
Active participation in trainings, maintenance, and development of quality system documents
Support in all PV operations associated with Medical Writing

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

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

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

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