Planet Pharma is hiring: Medical Writer III in Princeton
Planet Pharma, Princeton, NJ, United States, 08543
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Job Description
Target PR Range: 57-67/hr
- Depending on experience
- 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, i.e., Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management to obtain necessary information and to ensure the timely implementation of activities related to the production of reports.
- Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract medical 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 an in-depth evaluation of variable factors. Determines methods and procedures on new assignments. Physical Requirements: While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Occasional overnight travel may be required.
Skills: American Medical Writing Association (AMWA) certification or other is desirable, with a specialty in Pharmaceutical Writing. Preferred experience includes:
- 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 working with CNS/Neuroscience compounds.
- Ability to manage projects independently and lead/organize/participate in cross-functional teams.
- Journalism/press publications. Must possess:
- Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured ‘story’.
- Ability to self-edit and improve own work to ensure readability, accuracy, consistency and aesthetic presentation of data and information.
- Knowledge of clinical trial and drug development processes.
- Knowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions.
- Knowledge of Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation.
- Working knowledge of current electronic document management systems and publishing systems.
- Ability to assimilate, interpret and translate information/data for appropriate audiences.
- Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets.
- Ability to learn fast, grasp the 'essence' of a story quickly to convert relevant scientific data/information into high quality summaries and reports.
- Open to feedback and suggestions and innovation for improvement.
- Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization.
- Skilled at creating a cooperative team environment.
- Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
A PhD in a life science/Pharm D preferred with 5 or more years of relevant experience; MS with 7 or more years of relevant experience.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Seniority level
Seniority level
Not Applicable
Employment type
Employment type
Full-time
Job function
Job function
Marketing, Public Relations, and Writing/EditingIndustries
Staffing and Recruiting
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