Two Regulatory Writing Positions

A recruiter contacted me about open positions at VinCro Clinical Management Services, a full-service CRO that specializes in the management and placement of contract clinical staffing personnel. They are seeking contract Sr Medical Writers and Medical Editors with diabetes experience immediately. See below for details.

Title: Senior Medical Writer

Location: Northern NJ (3 days on-site, 2 days off-site/home office) (Near Hackensack)

Job Purpose: We are seeking a senior level medical writer to support Phase 1 / Pharmacokinetic studies involving diabetes. This is a full-time 3 month contract position with possibility of renewal based on candidate performance and company need.

Key Responsibilities:

1) Discuss, develop, produce, revise and/or update protocols and clinical study reports for preclinical and clinical studies

2) Responsible for developing IB's, components of Investigational New Drug, Clinical Trial Authorization, New Drug Application submissions, regulatory responses, and other clinical/regulatory documents.

3) Provide support to the assigned clinical development team to ensure clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines.

4) Mentor and train junior medical writers as required

5) Manage outside contractors as required

6) Facilitate conflict resolution across multi-disciplinary teams


Requirements

Minimum Bachelor's degree (BSN/MS/PhD/PharmD preferred) required in biological, nursing or medical sciences

5+ years of relevant medical writing experience including protocol writing

Project Management experience with a strong track record of planning and organizational skills with minimal supervision

Experience in pharmaceutical industry Phase I-II pharmacokinetic/pharmacodynamic research is required

Knowledge of the development, regulatory, quality, and compliance environment within the pharmaceutical and marketing environment

Strong interpersonal and communication skills

Familiarity with ICH and AMA guidelines

Proficiency in MSWord, Excel, and PowerPoint


Compensation: $85-100 per hour. Reasonable travel expenses will be reimbursed.



Title: Medical Editor

Location: NJ (3 days on-site, 2 days off-site/home office) (Near Hackensack)

Job Purpose: We are seeking a medical editor to proofread and edit research protocols, clinical study reports, medical writing templates as well as check IB’s, IND, CTA, NDA, regulatory responses and other clinical/regulatory documents for accuracy and flow. This is a full-time 3 month contract position.

Key Responsibilities:

1) Responsible for medical, technical and traditional editing and proofreading by ensuring correct grammar, spelling, and typography of approved documents

2) Preparation of medical writing templates

3) Proofread and edit protocols and clinical study reports for preclinical and clinical studies; Investigator’s Brochures; components of Investigational New Drug Applications, Clinical Trial Authorization, and New Drug Application submissions; regulatory responses; and other clinical/regulatory documents

4) Provide editorial support to the assigned clinical development team to ensure that clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines

5) May supervise and manage medical editing consultants in the absence of or as directed by Senior Manager, Medical Writing or Senior Director, Medical Writing


Requirements

Minimum Bachelor’s Degree in Communication, Physical Sciences, Medical Sciences, advanced degree an asset

2 years of pharmaceutical industry experience in regulatory, medical writing or clinical development arenas

Strong interpersonal and communication skills

Familiarity with eCTD, ICH and AMA guidelines

Proficiency in MSWord, Excel, and PowerPoint


Compensation

$45-65 per hour. Reasonable travel expenses will be reimbursed.


If interested, contact:

Shawn Varrin, M.Sc., M.B.A.
President
VinCro Clinical Management Services
6813 Sunset Blvd.,
Ottawa, Ontario, Canada
K4P 1M6
Ph - 613-526-4267
Fax 613-526-6200
Email: svarrin@vincro.com