Principal Medical Writer at Beacon Hill Staffing Group, LLC in Lexington, Massachusetts

Job Description:

Title: Principal Medical Writer (Regulatory)


Location: Hybrid (3-4 days onsite) Lexington, MA


Duration: Direct Hire


Salary + Bonus



RESPONSIBILITIES:



Responsibilities (including, But Not Limited To)

• Manages medical writing projects to prepare clinical/regulatory documentation (e.g., clinical study protocols, clinical study reports, investigator brochures, regulatory submission modules) in support of clinical development, clinical studies, and regulatory submissions, presenting clinical data objectively and clearly in a concise format consistent with industry guidelines


• Manages the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes


• Leads the technical editing activities for assigned projects and reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards


• Actively supports cross-functional project teams, representing Medical Writing and taking responsibility for timely and accurate Medical Writing deliverables, negotiating timelines as necessary


• Solves problems associated with Medical Writing scope of work, seeks advice from in-line management and others as needed, and exercises negotiation and communication skills with project team members


• May participate in orientation and coaching of junior team members or working in collaboration with Medical Writing contractors


• Participates in and leads within- and across-department efforts to continuously improve Medical Writing processes and standards


• Produces high-quality documents with minimal supervision to meet aggressive timelines, ensuring consistent messaging across appropriate documents (nonclinical, clinical, and product labeling)


• Stays up to date on and understands regulatory guidance regarding content for various clinical/regulatory documents and can apply this knowledge


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Qualifications

• 6+ years of specific medical writing experience in the pharmaceutical industry (including development of clinical study outlines, protocols, study reports, investigator brochures, and IND/BLA/NDA sections)


• Bachelor's, Masters, or PhD degree in science, medical, clinical, or English/Communications required.


• Ability to lead/manage multiple projects in a fast-paced environment handling multiple demands and experience with project management software (e.g., MS Project, Smartsheet)


• Strong working knowledge of Adobe PDF, MS WORD, EXCEL, and PowerPoint


• Experience with automated document templates and style guides


• Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and familiarity working according to established GCP standard operating procedures


• Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by the team

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.



California residents: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.


If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/


Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

Company Profile:


Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.


Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.


Learn more about Beacon Hill and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Life Sciences and Beacon Hill Technologies by visiting www.bhsg.com .

We look forward to working with you!


Beacon Hill. Employing the Future™
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