Associate Director, Medical Writing (Pharmacovigilance)

  • Location
    Princeton, New Jersey
  • Job type
    Direct Hire
  • Category
    Medical & Science - Pharmaceutical Preclinical Development

An Associate Director, Medical Writing (Pharmacovigilance) job near Princeton, New Jersey is anticipated courtesy of Adecco Medical and Science. This regulatory specialist works in partnership with the leadership of the Medical Writing Department and is the primary overseer and performer for the medical writing activities to ensure meeting regulatory requirements for clinical trial disclosure and ongoing drug safety and pharmacovigilance (PV) reporting. The person(s) in this role will both manage other writers (including permanent and contract/CRO employees) and work directly on documents/projects with cross-functional teams.

Associate Director, Medical Writing Responsibilities include:

Serving as the Disclosure and Drug Safety/PV Medical Writing Lead
Ensuring that documents are appropriate for their target audience while also meeting all regulatory requirements
Managing, leading, and/or assisting more junior writers and other medical writing-related staff (including contract or CRO staff)
Leading Disclosure and Drug Safety/PV medical writing vendor selection, contracting, and management
Building and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the medical writing community)
Performing document-specific tasks such as (a) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells, (b) ensuring editorial review of documents (grammar, punctuation, and formatting), and (c) ensuring quality-checking of documents (including for submission-ready formatting)
Ensuring compliance with templates and standard operating procedures (SOPs) and applying the principle of continuous improvement to all in-house and contracted medical writing procedures for safety and disclosure
Contributing to cross-functional team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
Providing training and guidance on Disclosure and Drug Safety/PV medical writing best practices
Participating in projection of annual budget and resource needs for Disclosure and Drug Safety/PV medical writing


QUALIFICATIONS:

The ideal candidate will possess a graduate level education
A minimum of 4 to 8 years’ experience with related work within a pharmaceutical company or CRO; all clinical or clinical research experience will be considered
Experience across most types of regulatory medical writing deliverables, with specific experience in regulatory documents to address results disclosure (e.g., CT.gov and EudraCT results reporting) and safety reporting requirements (e.g., IBs, DSURS, PBRERs, RMPs)
Experience with submissions-level safety documents/elements (Integrated Summary of Safety, Summary of Clinical Safety)
Must be able to plan activities of self and others, and manage the deliverables of others in accordance with pre-established timelines, while systematically performing activities in a timely and accurate manner
Demonstrated ability to independently make and execute strategic decisions, based on quickly digesting and assimilating pertinent information, and including leading cross-functional teams through execution
Demonstrated ability to translate technical information from mixed sources into written information suitable for an audience of clinicians and regulatory authorities while summarizing data that enables reaching conclusions and exercising judgment to move projects forward
Training in the biomedical sciences, as well as experience in technical written communication and working cross-functionally, including with partner companies and vendors
Advanced writing and speaking competency
Positive and proactive communication skills, including effective meeting planning and management
Experience in managing junior colleagues, including supporting their career development
Experience in selecting, contracting, and managing contract writers/ writing vendors
Proficiency with the Microsoft Office Suite, including MS Project
Demonstrated high attention to detail, including capacity to catch and resolve issues not caught by more junior level quality checking


If you are interested in this Associate Director, Medical Writing job near Princeton, New Jersey then please click APPLY NOW or contact Eric Wilson at eric.s.wilson@adeccona.com

For other opportunities available at Adecco Medical and Science go to www.adeccousa.com.


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Reference number US_EN_2_106405_329609