Russell Tobin
Overview
Russell Tobin is seeking an
Associate Director Medical Writer
for a biopharmaceutical company known for trailblazing breakthroughs for people with neurological conditions. Job Title:
Associate Director Medical Writer Location:
Princeton, NJ Job Type:
Contract Length:
10/01/2025 – 09/01/2027 Hours:
Initially, typically only ~15-25 hours per week are utilized for onboarding and training. If performance is strong, this position could be full time. Pay Rate:
$60.00 - $73.65 per hour Responsibilities
Acts as medical writing point person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions. Participates in and contributes to the development of the submission communication strategy for a product. Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text. Liaises with internal groups (Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management) to obtain information and ensure timely production of reports. Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract writers and agencies, with support from Director Medical Writing. Fosters innovation and improvement related to medical writing processes and documents, with support from Director Medical Writing. Other responsibilities as assigned. Scope
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires in-depth evaluation of variable factors. Determines methods and procedures on new assignments. Physical Requirements
Regularly required to stand, walk, sit, use hands, reach with hands and arms, climb or balance, stoop, kneel, crouch, see, talk or hear in a standard office environment and during remote work. May occasionally lift and/or move up to 20 pounds. Occasional overnight travel may be required. Skills
AMWA certification or equivalent desirable, with a specialty in Pharmaceutical Writing. Qualifications and Experience
3+ years in medical writing for the pharmaceutical industry, with a focus on regulatory document preparation; knowledge of drug development process and regulatory guidelines. Specific experience with CNS/Neuroscience compounds. Ability to manage projects independently and lead/organize/participate in cross-functional teams. Strong writing skills and the ability to convert scientific data into clear, scientifically sound summaries and reports. Knowledge of US, ICH and international regulations related to scientific and regulatory document preparation and submissions. Working knowledge of electronic document management and publishing systems; proficiency in Windows software (word processing, flow diagrams, spreadsheets). Ability to learn quickly and convey complex information to diverse audiences. Openness to feedback and continuous improvement; ability to foster a cooperative team environment. Education
A PhD in a life science or PharmD is preferred with 5+ years of relevant experience; MS with 7+ years may be considered. Benefits
Russell Tobin offers eligible employees comprehensive healthcare coverage (medical, dental, and vision), supplemental coverage (accident, critical illness, hospital indemnity), a 401(k) retirement plan, life and disability insurance, employee assistance program, identity protection, legal support, auto/home/pet insurance, and employee discounts with select vendors. Apply
To apply:
If you are interested in the position, please email your resume to rob.vanriet@russelltobin.com for immediate consideration. Job Details
Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Science and Writing/Editing Industries:
Biotechnology Research and Pharmaceutical Manufacturing Note: This description reflects the original information provided and has been reformatted for clarity and compliance with the requested tagging rules.
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Russell Tobin is seeking an
Associate Director Medical Writer
for a biopharmaceutical company known for trailblazing breakthroughs for people with neurological conditions. Job Title:
Associate Director Medical Writer Location:
Princeton, NJ Job Type:
Contract Length:
10/01/2025 – 09/01/2027 Hours:
Initially, typically only ~15-25 hours per week are utilized for onboarding and training. If performance is strong, this position could be full time. Pay Rate:
$60.00 - $73.65 per hour Responsibilities
Acts as medical writing point person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions. Participates in and contributes to the development of the submission communication strategy for a product. Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text. Liaises with internal groups (Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management) to obtain information and ensure timely production of reports. Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract writers and agencies, with support from Director Medical Writing. Fosters innovation and improvement related to medical writing processes and documents, with support from Director Medical Writing. Other responsibilities as assigned. Scope
Uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires in-depth evaluation of variable factors. Determines methods and procedures on new assignments. Physical Requirements
Regularly required to stand, walk, sit, use hands, reach with hands and arms, climb or balance, stoop, kneel, crouch, see, talk or hear in a standard office environment and during remote work. May occasionally lift and/or move up to 20 pounds. Occasional overnight travel may be required. Skills
AMWA certification or equivalent desirable, with a specialty in Pharmaceutical Writing. Qualifications and Experience
3+ years in medical writing for the pharmaceutical industry, with a focus on regulatory document preparation; knowledge of drug development process and regulatory guidelines. Specific experience with CNS/Neuroscience compounds. Ability to manage projects independently and lead/organize/participate in cross-functional teams. Strong writing skills and the ability to convert scientific data into clear, scientifically sound summaries and reports. Knowledge of US, ICH and international regulations related to scientific and regulatory document preparation and submissions. Working knowledge of electronic document management and publishing systems; proficiency in Windows software (word processing, flow diagrams, spreadsheets). Ability to learn quickly and convey complex information to diverse audiences. Openness to feedback and continuous improvement; ability to foster a cooperative team environment. Education
A PhD in a life science or PharmD is preferred with 5+ years of relevant experience; MS with 7+ years may be considered. Benefits
Russell Tobin offers eligible employees comprehensive healthcare coverage (medical, dental, and vision), supplemental coverage (accident, critical illness, hospital indemnity), a 401(k) retirement plan, life and disability insurance, employee assistance program, identity protection, legal support, auto/home/pet insurance, and employee discounts with select vendors. Apply
To apply:
If you are interested in the position, please email your resume to rob.vanriet@russelltobin.com for immediate consideration. Job Details
Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Science and Writing/Editing Industries:
Biotechnology Research and Pharmaceutical Manufacturing Note: This description reflects the original information provided and has been reformatted for clarity and compliance with the requested tagging rules.
#J-18808-Ljbffr