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Senior Medical Writer Clinical – Pharmaceuticals (Remote)

A Line Staffing Solutions

This is a Contract position in Dallas, TX posted December 11, 2021.

Full time Principal Medical Writer (Remote) openings based out of the North Chicago, IL 60044 area with a major healthcare company Starting ASAP Apply now with Luke H.

at A-Line Job Description:
• The Principal Medical Writer is responsible for providing clinical regulatory document support to the clinical teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the writing process.

• Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.

• Interfaces with external groups (e.g.

PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of clinical regulatory submissions.

• Serves as the scientific writing content expert for the department.

Pay: $70
– $85 hourly (determined on experience) Hours: 8 hours per day, core hours 9am to 3pm CST, half hour or hour for lunch.

(Some OT expected.) Responsibilities:
• Serves as medical writing lead on more complex clinical regulatory documents such as those associated with filings and dossiers.

Works closely with the Regulatory team(s) on document strategies.

Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).

• Serves as a subject matter expert within department for assigned therapeutic/product areas.

As assigned, provides direction and guidance to medical writers regarding assigned projects, including review of work product.

Provides input and feedback to management regarding internal medical writers’ work product/quality.

Recognizes potential scheduling and resource conflicts for projects across therapeutic area/product assignments and provides recommendations to resolve.

• Converts relevant data and information into a form that meets clinical regulatory document requirements.

Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects.

Arranges and conducts review meetings with the team.

• Communicates deliverables needed, writing process, and timelines to team members.

Holds team members accountable to agreed-upon project dates.

Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands (time, deliverables, etc.).

Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.

• Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors.

Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables.

Verifies that results are consistent with protocols.

Confirms completeness of info to be presented.

Challenges conclusions when necessary.

Independently resolves document content issues and questions.

• Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.

· Performs literature searches as needed for drafting document content.

Interprets literature information and makes recommendations for application to clinical regulatory documents.

• Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate) and works with team to draft responses as necessary.

• Maintains expert knowledge of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions.

Advises teams regarding compliance with clinical regulatory document content as defined in regulations.

Must continually train/be compliant.

• Serves as a department representative on project teams.

Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g.

eDocs and eCTD databases).

Coaches, mentors, and assists medical writers.

Provides guidance to medical writers and external vendors/agencies.

Recommends, leads, and implements tactical process improvements, both within the department and division-wide.

Qualifications:
• Bachelor of Science required, with significant relevant writing experience, or Bachelor’s degree in English or communications, with significant relevant science experience.

Masters or PhD in science discipline preferred with relevant writing experience.

• 4 years’ relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.

• 4 years’ experience in experimental design and clinical/preclinical data interpretation preferred.

• High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required.

Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.

Working knowledge of statistical concepts and techniques.

• Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.

Knowledge and expertise with Common Technical Document content templates.

Expert knowledge of current electronic document management systems and information technology.

• Expert in word processing, flow diagrams, and spreadsheets.

Excellent working knowledge of software programs in Windows environment.

• Extensive experience in working with collaborative, cross-functional teams, including project management experience.

• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.

Why Apply:
· Full benefits available after 90 days: Medical, Dental, Vision, Life, Short-term Disability
· 401k after 1 year of employment: With employer match and profit sharing
· GREAT Hours Monday through Friday, 40 hours per week
· Competitive Pay Rate Keywords: Regulatory Compliance, Clinical Writer, Medical Writer, Pharmaceutical, Biotech, Big-Pharma, Clinical Trials, Regulatory Affairs, CMC, Clinical Research, Biology, Chemistry, R&D, Research & Development, Regulatory Documents, Clinical, Medical, Pharmacology, Phase II-IV, Clinical Trials, Healthcare, Pharmacy, MCO, Managed Care Organization, Lab, Laboratory, Regulatory Quality Assurance, Quality Assurance.

Job Requirements:
• Bachelor of Science required, with significant relevant writing experience, or Bachelor’s degree in English or communications, with significant relevant science experience.

Masters or PhD in science discipline preferred with relevant writing experience.

• 4 years’ relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.

• 4 years’ experience in experimental design and clinical/preclinical data interpretation preferred.

• High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required.

Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.

Working knowledge of statistical concepts and techniques.

• Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.

Knowledge and expertise with Common Technical Document content templates.

Expert knowledge of current electronic document management systems and information technology.

• Expert in word processing, flow diagrams, and spreadsheets.

Excellent working knowledge of software programs in Windows environment.

• Extensive experience in working with collaborative, cross-functional teams, including project management experience.

• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.

Keywords: Regulatory Compliance, Clinical Writer, Medical Writer, Pharmaceutical, Biotech, Big-Pharma, Clinical Trials, Regulatory Affairs, CMC, Clinical Research, Biology, Chemistry, R&D, Research & Development, Regulatory Documents, Clinical, Medical, Pharmacology, Phase II-IV, Clinical Trials, Healthcare, Pharmacy, MCO, Managed Care Organization, Lab, Laboratory, Regulatory Quality Assurance, Quality Assurance.

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