Medical Writing Manager in Pleasanton, CA at Apex Life Sciences

Date Posted: 9/27/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Medical Writer Manager to oversee a team that delivers and executes the following documents: Clinical Study Documents, Clinical Validation Plans, Protocols, Clinical Study Reports, Instructions for Use and/or Package Inserts, Scientific Communications, Abstracts, Scientific Posters, White Papers, Literature Reviews, Scientific Manuscripts, Publication Alerts, etc.


Responsibilities:

  • Accountable for and manages day-to-day activities of the Medical Writing team, such as assignment delegation, performance reviews, professional development/coaching, budgeting and time-tracking, process improvement, document standardization and KPI reporting/tracking.
  • Independently leads process improvement initiatives, such as updating internal SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc.
  • Periodically communicates team activities, progress, and goals to leadership through one-on-one (e.g., in-person meetings, emails) and group communications (e.g., PowerPoint presentations)
  • For selected and high priority medical documents, will serve as primary point of contact with oversight and management responsibility for the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals), and submission (interface with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.)
  • Partners with the Publications Manager to assign (to the Medical Writing team) and complete selected Scientific Communications.
  • Collaborates with other Medical Writing teams within the company to share best practices, harmonize documents and improve related processes/procedures.
  • Effectively communicates and builds healthy working relationships with Medical Writing team members and key stakeholders throughout the organization with whom he/she will work closely.
  • Actively participates in Medical Writing team meetings and activities.
  • Successfully completes all assigned curricula and on-the-job training modules.
  • Performs his/her work in accordance with company cultural beliefs and agreed upon Key Performance Indicators (KPIs).
  • Provides appropriate and transparent notification for work absences.
  • The Essential Responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as required.


Qualifications:

  • Masters degree in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields required
  • English proficiency (both spoken and written)
  • Preferred: Doctoral degree or higher (e.g., PhD, PharmD, DVM) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields English as a primary language
  • 5+ years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports required
  • Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA).
  • Supervisory and/or project management experience
  • Submission and publication management of scientific manuscripts to at least 5 different journals required
  • 10+ years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports preferred
  • Submission and publication management of scientific manuscripts to at least 10 different journals desired
  • Experience with in vitro diagnostics, molecular diagnostics and/or Infectious Disease Knowledge of drug development (e.g., pharmacokinetics, biostatistics, nonclinical and clinical research)
  • Process improvement and/or Six Sigma training desired
  • Knowledge and understanding of the clinical research process, including ICH GCP and FDA regulations
  • Knowledge on Good Publication Practices
  • Experience in working with Templates, Style Guides, SharePoint and Document Management Tools
  • Calendar management skills/ expertise using Google Calendar
  • Reference management skills/ expertise with EndNote preferred 
  • Meticulous attention to detail
  • Strong interpersonal and communication skills, including conflict resolution and influencing
  • Comfortable with virtual work environments and meetings
  • Ability to work effectively in a fast-paced environment and with multiple high priority projects
  • Ability to problem solve and delegate appropriate tasks to collaborators and follow-up as needed to meet deadlines

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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