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Pharma/Medical/Clinical Writer - Kenilworth, NJ (Fully remote)

In New Jersey / United States

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Pharma/Medical/Clinical Writer - Kenilworth, NJ (Fully remote)   

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JOB TITLE:

Pharma/Medical/Clinical Writer - Kenilworth, NJ (Fully remote)

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Kenilworth New Jersey / United States

JOB DESCRIPTION:

Job Title Pharma/Medical/Clinical Writer

Location Kenilworth, New Jersey (Fully remote)

Duration 8 months - Possible 3 month extension

Qualifications:

Degree in the Life Sciences - Bachelor's degree with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience.

MUST HAVE SKILLS:

  • Experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
  • Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • Participate actively in medical writing and cross-functional project teams.
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
  • Excellent oral (including presentation) and written communication, and project management skills.
  • Awareness of pharmaceutical industry needs beyond clinical development.
  • 3-8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
  • Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • Participate actively in medical writing and cross-functional project teams.
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
  • Excellent oral (including presentation) and written communication, and project management skills.
  • Awareness of pharmaceutical industry needs beyond clinical development.
  • Ability to work weekends

Responsibilities:

  • Acts a capable scientific contributor and subject matter expert in preparation of selected scientific response documents (SRD).
  • Applies developing knowledge of medical writing and therapeutic area/investigational product to support projects around dissemination and communication of projects surrounding medical congresses.
  • Participates as part of the medical writing team in cross-functional teams.
  • Demonstrates competence in writing, editing and reviewing of SRDs in line with expectations.
  • Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to congress portal preparation.
  • Manages medical writing projects including the design, planning, and preparation of documentation in support of company goals.
  • Works collaboratively with colleagues across functions to achieve results.
  • Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members.
  • Creating materials for field medical scientific exchange Duration: About

Position Details

POSTED:

Jun 23, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864312762568

LOCATION:

New Jersey / United States

CITY:

Kenilworth

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

Pharma/Medical/Clinical Writer - Kenilworth, NJ (Fully remote)    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Job Title Pharma/Medical/Clinical Writer

Location Kenilworth, New Jersey (Fully remote)

Duration 8 months - Possible 3 month extension

Qualifications:

Degree in the Life Sciences - Bachelor's degree with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience.

MUST HAVE SKILLS:

  • Experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
  • Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • Participate actively in medical writing and cross-functional project teams.
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
  • Excellent oral (including presentation) and written communication, and project management skills.
  • Awareness of pharmaceutical industry needs beyond clinical development.
  • 3-8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry.
  • Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
  • Participate actively in medical writing and cross-functional project teams.
  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
  • Excellent oral (including presentation) and written communication, and project management skills.
  • Awareness of pharmaceutical industry needs beyond clinical development.
  • Ability to work weekends

Responsibilities:

  • Acts a capable scientific contributor and subject matter expert in preparation of selected scientific response documents (SRD).
  • Applies developing knowledge of medical writing and therapeutic area/investigational product to support projects around dissemination and communication of projects surrounding medical congresses.
  • Participates as part of the medical writing team in cross-functional teams.
  • Demonstrates competence in writing, editing and reviewing of SRDs in line with expectations.
  • Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to congress portal preparation.
  • Manages medical writing projects including the design, planning, and preparation of documentation in support of company goals.
  • Works collaboratively with colleagues across functions to achieve results.
  • Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members.
  • Creating materials for field medical scientific exchange Duration: About


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