Senior Medical Writer Senior Regulatory Writer job Raleigh North Carolina
Senior Medical Writer   Senior Regulatory Writer job Raleigh North Carolina
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Senior Medical Writer / Senior Regulatory Writer Job



Employer Name: Advanced Recruiting Partners SpiderID: 7992523
Location: Raleigh, North Carolina Date Posted: 9/24/2018
Wage: $75/hr. - $100/hr. Category: Biotech
Job Code:
Number Of Openings: 4

Job Description:
JOB SUMMARY for the Senior Medical Writer / Senior Regulatory Writer: Phase 1-3 protocols and clinical study reports (CSRs); summary documents (including Integrated Summary of Safety [ISS], Integrated Summary of Efficacy [Client], Clinical Overview, Clinical Summary), risk management plans (as needed), and clinical study summaries (for posting to study registries); and clinical parts of Investigational Drug Brochures, agency meeting briefing packages, INDs, modules for NDAs, and EU Annual Safety Updates, and responses to agency questions; and other documents that may be assigned. It is the responsibility of the Senior Medical Writer / Senior Regulatory Writer to:

• Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) compliant presentation.
• Prepare clinical submission documents for a regulatory audience, within a team environment, according to SOPs and templates.
• Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner. Provide process, content, and submission/document planning expertise to Clinical Submission Team, Clinical Satellite Team, and Clinical Trial Team. Advise team on resource utilization, efficiencies, timelines, and interdependencies. Participate in and/or lead the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines. Share expertise within Medical Writing / Regulatory Writing by coaching/mentoring Medical Writers / Regulatory Writers.

Interested candidates please send your resume to Wesley Garrett at wgarrett@advancedrecruitingpartners.com for consideration.


Job Requirements:
MAJOR ACCOUNTABILITIES for the Senior Medical Writer / Senior Regulatory Writer:

• Write and prepare clinical submissions documents within a team environment.
• Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) compliant presentation.
• Manage the review and approval process of clinical submissions documents; notify team of targeted review responsibilities. Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner.
• Review and comment on documents in clinical program (e.g., protocols and statistical analysis plans) associated with project assignments.
• Act as Clinical Program Medical Writer / Regulatory Writer (as assigned). Provide process, content, and planning expertise to Clinical Trial Team, Clinical Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing / Regulatory Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style.
• Coordinate with other Clinical Program Medical Writers / Regulatory Writers as needed to maintain consistency across documents within a project and across indications.
• Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents. Continually share best practices to create higher quality documents more efficiently.
• Maintain and demonstrate expert knowledge of drug development process and applicable regulatory guidelines.
• Maintain and demonstrate expert knowledge of company- and project-specific guidelines for the generation of clinical submissions documents, including SOPs, templates, and document writing conventions and styles.
• Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced.
• Mentor, coach, and/or otherwise assist in the training and development of Medical Writers / Regulatory Writers. Such other responsibilities and projects as the company may assign.

EDUCATION & QUALIFICATION for the Senior Medical Writer / Senior Regulatory Writer: Describe the minimum level of education necessary for this role:
Bachelor's Degree, Master's Degree or PhD and other Professional certifications (e.g., AMWA, EMWA, RAPS, etc.) is a plus, but not essential. Certification (Describe): Six or more years’ experience in Medical Writing / Regulatory Writing in the Biopharmaceutical industry. An advanced degree (e.g., MS, PhD, etc.) may be considered in lieu of years of experience.

COMPETENCIES for the Senior Medical Writer / Senior Regulatory Writer: Include specific skills, behaviors and knowledge necessary to meet the objectives of the role. Specific skills (Include specific skills and knowledge necessary to meet the objectives of the position).
Additional requirements include:

• Ability to work without close supervision.
• Ability to multi-task and to respond rapidly to changing priorities and aggressive timelines.
• Ability to work within an international team.
• Must be detail-oriented, thorough, and methodical.
• Excellent written and verbal communication skills.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Excellent problem-solving capabilities and organizational skills.
• Expert knowledge of medical, pharmaceutical, and clinical research concepts.
• Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
• A high degree of familiarity with statistical and data output.
• Expert knowledge of the methods, techniques, and procedures of medical writing tasks.
• Prior CSR and Summary Document generation experience, preferably at a sponsor.
• Prior experience with submissions in Common Technical Document (CTD) format.
• Knowledge of Technology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
• Detailed and experienced-based understanding of applicable regulations, Common Technical Document structure and content, including CSR and summary document content.
• Detailed and experience-based understanding of applicable regulations and guidelines (e.g., Code of Federal Regulations, European Directive, and International Conference on Harmonization).
• Strong computer skills; proficiency in MS Word.
• Problem solving (Describe the level of "self-starting” thinking required in the for recognizing, analyzing and solving problems).
• Can manage uncertainty and shifting priorities and timelines.
• Able to adapt to working in a multicultural environment; able to adapt to change.
• Able to think independently and apply principles across various situations and appropriately apply judgment to making changes.
• Able to adopt an entrepreneurial and innovative style when necessary.


Job Criteria:
Start Date: 10/15/2018
Position Type: Contractor
Years of Experience Required: 10 or more
Education Required: Bachelors
Overnight Travel:
Vacation Time: 2 weeks / year


Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Tuition Reimbursement

Contact Information:
Contact Name: Wesley Garrett Company Type: Staffing Agency
Company: Advanced Recruiting Partners
City: Raleigh
State: North Carolina
Zip: 27613

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