Assistant Medical Writer Job at AdMed, Inc. (Philadelphia)

Content Writer (Medical Device)

The Content Writer (Medical Device) will author, review, update, and maintain te...

Location

United States , New York

Salary:

40.00 - 45.00 USD / Hour

Daley and Associates

Expiration Date

Until further notice

Requirements

Bachelor’s degree in English, Health Sciences, Communication, Marketing, or related field
3-5+ years of technical writing, content management, and/or digital publishing experience in the medical device industry (required)
Minimum of 3 years’ experience utilizing MadCap Flare for technical writing and content management (required)
Excellent written and verbal communication skills
Proficiency in desktop publishing tools, such as Microsoft Office Suite, MadCap Flare, and Adobe FrameMaker
Familiarity with global labeling requirements
Excellent understanding of structured documentation and document version control
Detail-oriented and highly organized with a demonstrated ability to manage competing priorities
Ability to work independently and collaboratively to deliver quality results

Job Responsibility

Craft and deliver content in MadCap Flare, leveraging condition tags and variables, content reuse strategies, and multichannel publishing outputs (especially so for PDF publishing)
Develop, update, and maintain content, including, but not limited to, reference guides, user manuals, instructions for use (IFUs), and package inserts
Assist in design control processes, ensuring timeliness, accuracy, and compliance
Contribute to process improvement efforts related to style guides, templates, and publishing workflows
Review design deliverables, risk management documentation, and verification/validation documents for consistency with instructions for use (IFUs) content
Execute documentation changes through formal change control (ECO)
Work closely with internal teams (Marketing, Regulatory Affairs, Quality, and Engineering) to ensure documentation alignment with product requirements
Translate specialized product needs, customer needs, operational policies and processes, and product use into feasible documentation requirements and recommendations
Leverage knowledge of industry topics and business functions in executing core job functions
Perform additional duties as needed

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

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

Contract Recruiter

We’re looking for a contract / fractional recruiter to support a focused hiring ...

Location

United States

Salary:

Not provided

AdMed, Inc.

Expiration Date

Until further notice

Requirements

Experience recruiting medical writers and other agency medical communications roles
Comfortable owning searches end-to-end (sourcing → screens → shortlist)
Experience working in an ATS (Workable preferred) and LinkedIn Recruiter
Prioritizes quality over volume

What we offer

Work with a longstanding leader in pharmaceutical marketing and training
Direct partnership with senior leadership
Flexible, remote work arrangement
Short-term, high-impact engagement
Competitive hourly compensation

Parttime

Principal Physician, Patient Safety

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Expertise in drug safety and the drug development process
Demonstrated success in technical proficiency and scientific creativity
Ability to work on complex problems requiring in-depth evaluation
Ability to exercise judgment within broadly defined practices and policies
Good presentation and verbal/written communication skills
Good interpersonal skills
Client focused approach to work
Demonstrated ability to balance technical expert responsibilities with people management duties when assigned
Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Communicating and discussing issues related to review process with Line Manager/Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections, Act as a Subject Matter Expert during Audits/inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

Fulltime

Select Country

Assistant Medical Writer

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?