Job title: Medical Writer III - 100% Remote
Duration: 12 months (possible extension)
The hours per week may start at closer to 20 hours/week and then ramp up to 30 or 40 hours based on how quickly training is completed and how independently the writer is able to work.
 
Description:

• Looking for someone at an associate director level of medical writing with minimum of 3 years in pharma space with phase 1 pharmacology experience with protocols.

 
Position Summary:

• The primary responsibilities of an Associate Director Medical Writer at ACADIA include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics.
• These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information).
• The Associate Director Medical Writer has a broad range of experience in pharmaceutical medical writing and clinical/pharmaceutical development and knowledge of current regulatory guidelines.

 
Primary 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, 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.
• 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.

 
Education:

• 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.

 

About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
 
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $68.00/hr.