Job Details: Technical Writer


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Technical Writer
Global Scientific Communications Associate - Regulatory

Our client makes a difference for people the world over by
discovering, developing and delivering medicines that help people live
longer, healthier and more active lives. Central to all that we do are
our talented and motivated professionals, circa **Apply on the
website** of whom are based at our Global Business Solutions Centre in
Little Island, Cork. There we boast vibrant workforce made up of over
**Apply on the website** nationalities.

Scientific data and information are core assets of our client.
Providing balanced, objective, and accurate information to regulators,
the scientific community, health care professionals, payers, and
patients in a consistent and timely fashion across the entire drug
development lifecycle is fundamental to our client.

Responsibilities

1.Content Strategy and Execution: Document Preparation, Development
and Finalization/Document Management

Effectively collect and evaluate data, information, and input from
multiple sources, functions, and regions to create a cohesive content
strategy for writing projects.

Plan (including organizing/preparing outlines), write (including
first-draft authoring), edit, review, coordinate, and complete the
regulatory documents supporting clinical development/product
registration.

Conduct effective document initiation meeting to ensure authoring team
alignment and understanding.

Build scientific-based rationale that support the purpose of more
complex and/or strategic documents.

Ensure data are presented in a clear, complete, accurate, and concise
manner.

Ensure that key data, statements and conclusions are consistent across
related documents, and that statements and conclusions are integrated,
accurate, balanced and supported by appropriate data.

Coordinate expert/scientific reviews, collate reviewer&#**Apply on the
website**;s comments, adjust content of document as required based on
internal/external input, and prepare final version.

Ensure and coordinate quality checks for accuracy.

Exhibit flexibility in moving across development and preparation of
multiple document types.

Influence or negotiate change of timelines and content with other team
members.

Work with internal and external experts to develop and prepare
presentations.

As needed, may build and manage relationships with vendors/alliance
partners.

2.Project and Stakeholder management

Lead the writing process ?effective project management skills to
ensure timely completion of high-quality regulatory documents.

Build/communicate credible writing project timelines.

Anticipate and mitigate risks to delivery

Work with teams and stakeholders to ensure smooth and timely
development of documents and escalate issues, as appropriate, to
ensure document completion.

Effectively communicate project status to stakeholders

3.Knowledge and Skills Development

Maintain and enhance therapeutic area knowledge including disease
state and compound(s) for assigned project(s).

Exhibit flexibility in moving across document types, therapeutic
areas, and compounds, depending on project assignment.

Maintain and enhance knowledge of regulatory guidelines and
publication guidelines.

Possess overarching view of compound, therapeutic area, and external
environment (including competitors) with ability to participate
effectively in clinical planning, submission strategy planning,
customer regulatory responses, and/or current awareness literature
updates and reviews.

Maintain and enhance the scientific communications skills to align
with the audience needs and with the changes in technology and
platforms.

4. Knowledge Sharing

Provide coaching to others by sharing technical information, giving
guidance, answering questions.

Recognized for technical expertise in specific document development.

Network with others (including other functions and regions) to
identify and share best practices.

Contribute to process improvements, suggesting opportunities where
appropriate.

Provide database and other tool (e.g., document management systems)
expertise.

Basic Qualifications

Bachelor&#**Apply on the website**;s degree in a scientific, health,
communications, technology health related field.

Demonstrated experience in technical/ regulatory scientific writing.

Strong communication and interpersonal skills.

Successful completion of writing exercise (a writing exercise is
required as part of the candidate evaluation process)

Additional Skills/Preferences

Graduate degree with formal research component or in life sciences.

Demonstrated mastery of verbal and written English skills in the
medical, scientific or technical writing fields.

Clinical pharmacology, therapeutic area, or other medical and
scientific specific knowledge and experience specific to hiring area
(e.g., neuroscience, oncology, cardiovascular, immunology or endocrine
expertise).

Experience writing regulatory, clinical trial documents and/or
publications

Experience in clinical development, clinical trial process or
regulatory activities.

Demonstrated project management and time management skills.

Demonstrated high-level end-user computer skills (e.g., word
processing, tables and graphics, spreadsheets, presentation and
templates).

Additional Information

The purpose of the Scientific Communications Associate - Regulatory
role is to work with cross-functional, multidisciplinary teams to lead
the development of documents intended for regulatory audiences
(including, but not limited to, clinical study reports, briefing
documents, regulatory responses, Investigational New Drug
Applications, and marketing authorization applications) Global Scientific Communications Associate - Regulatory

Our client makes a difference for people the world over by
discovering, developing and delivering medicines that help people live
longer, healthier and more active lives. Central to all that we do are
our talented and motivated professionals, circa **Apply on the
website** of whom are based at our Global Business Solutions Centre in
Little Island, Cork. There we boast vibrant workforce made up of over
**Apply on the website** nationalities.

Scientific data and information are core assets of our client.
Providing balanced, objective, and accurate information to regulators,
the scientific community, health care professionals, payers, and
patients in a consistent and timely fashion across the entire drug
development lifecycle is fundamental to our client.

Responsibilities

1.Content Strategy and Execution: Document Preparation, Development
and Finalization/Document Management

Effectively collect and evaluate data, information, and input from
multiple sources, functions, and regions to create a cohesive content
strategy for writing projects.

Plan (including organizing/preparing outlines), write (including
first-draft authoring), edit, review, coordinate, and complete the
regulatory documents supporting clinical development/product
registration.

Conduct effective document initiation meeting to ensure authoring team
alignment and understanding.

Build scientific-based rationale that support the purpose of more
complex and/or strategic documents.

Ensure data are presented in a clear, complete, accurate, and concise
manner.

Ensure that key data, statements and conclusions are consistent across
related documents, and that statements and conclusions are integrated,
accurate, balanced and supported by appropriate data.

Coordinate expert/scientific reviews, collate reviewer&#**Apply on the
website**;s comments, adjust content of document as required based on
internal/external input, and prepare final version.

Ensure and coordinate quality checks for accuracy.

Exhibit flexibility in moving across development and preparation of
multiple document types.

Influence or negotiate change of timelines and content with other team
members.

Work with internal and external experts to develop and prepare
presentations.

As needed, may build and manage relationships with vendors/alliance
partners.

2.Project and Stakeholder management

Lead the writing process ?effective project management skills to
ensure timely completion of high-quality regulatory documents.

Build/communicate credible writing project timelines.

Anticipate and mitigate risks to delivery

Work with teams and stakeholders to ensure smooth and timely
development of documents and escalate issues, as appropriate, to
ensure document completion.

Effectively communicate project status to stakeholders

3.Knowledge and Skills Development

Maintain and enhance therapeutic area knowledge including disease
state and compound(s) for assigned project(s).

Exhibit flexibility in moving across document types, therapeutic
areas, and compounds, depending on project assignment.

Maintain and enhance knowledge of regulatory guidelines and
publication guidelines.

Possess overarching view of compound, therapeutic area, and external
environment (including competitors) with ability to participate
effectively in clinical planning, submission strategy planning,
customer regulatory responses, and/or current awareness literature
updates and reviews.

Maintain and enhance the scientific communications skills to align
with the audience needs and with the changes in technology and
platforms.

4. Knowledge Sharing

Provide coaching to others by sharing technical information, giving
guidance, answering questions.

Recognized for technical expertise in specific document development.

Network with others (including other functions and regions) to
identify and share best practices.

Contribute to process improvements, suggesting opportunities where
appropriate.

Provide database and other tool (e.g., document management systems)
expertise.

Basic Qualifications

Bachelor&#**Apply on the website**;s degree in a scientific, health,
communications, technology health related field.

Demonstrated experience in technical/ regulatory scientific writing.

Strong communication and interpersonal skills.

Successful completion of writing exercise (a writing exercise is
required as part of the candidate evaluation process)

Additional Skills/Preferences

Graduate degree with formal research component or in life sciences.

Demonstrated mastery of verbal and written English skills in the
medical, scientific or technical writing fields.

Clinical pharmacology, therapeutic area, or other medical and
scientific specific knowledge and experience specific to hiring area
(e.g., neuroscience, oncology, cardiovascular, immunology or endocrine
expertise).

Experience writing regulatory, clinical trial documents and/or
publications

Experience in clinical development, clinical trial process or
regulatory activities.

Demonstrated project management and time management skills.

Demonstrated high-level end-user computer skills (e.g., word
processing, tables and graphics, spreadsheets, presentation and
templates).

Additional Information

The purpose of the Scientific Communications Associate - Regulatory
role is to work with cross-functional, multidisciplinary teams to lead
the development of documents intended for regulatory audiences
(including, but not limited to, clinical study reports, briefing
documents, regulatory responses, Investigational New Drug
Applications, and marketing authorization applications)

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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