Head of Regulatory Medical Writing Job

Job description

Head of Regulatory Medical Writing-000011HNDescriptionJanssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Head Regulatory Medical Writing, located in Titusville or Raritan, NJ, Spring House, PA or in Beerse, Belgium.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.
JanssenRnD.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Head of Regulatory Medical Writing (RegMW) is accountable for setting the strategy and operational execution, related to medical writing activities and deliverables within Integrated Data Analytics and Reporting (IDAR
- data management, risk management – central monitoring, statistical programming and medical writing), in line with R&D and Medical Affairs’ priorities and Therapeutic Area objectives, in close collaboration with the Project Delivery Liaison Head and the IDAR liaisons, the Global Clinical Development Operations (GCDO) Portfolio Delivery groups and Quantitative Sciences (QS), in order to ensure IDAR and GCDO success in efficiently providing high quality deliverables.
The Head of Regulatory Medical Writing (RegMW) is Accountable for RegMW resource management and allocation.
Responsible for the management and development of all employees within the organization to meet current and future business needs.
This position is expected to be capable of representing IDAR in their leadership capacity.
The Head of Regulatory Medical Writing (RegMW) is Accountable for setting the strategy and operational execution related to medical writing activities and deliverables of the Regulatory Medical Writing group. This includes:Establishes the strategy and direction of Regulatory Medical Writing within IDAR in line with IDAR, GCDO and RDO strategic objectives.
Interacts with IDAR and GCDO leaders to establish organizational priorities, ensures alignment of RegMW, and executes on the organizational priorities, with a focus on quality RegMW deliverables.
Oversees the global RegMW team and assures timely completion of deliverables for all areas of clinical research within the assigned therapeutic areas.
Overviews adequate resource planning, prioritization, and allocation to ensure programs and projects within therapeutic areas are optimally supported.
Ensures the RegMW strategy and processes are clear towards all stakeholders by organizing clear and consistent communication around it.
The Head of Regulatory Medical Writing (RegMW) is Accountable to ensure that the Regulatory Medical Writing services are in step with
- or ahead of best practices in the industry with regard to effectiveness and efficiency, and ensures continuous evaluation, benchmarking, and process improvement.
Accountable for the development and consistent implementation of Regulatory Medical Writing processes,Ensures compliance to departmental, company and industry policies and requirements; also ensures that up-to-date technology platforms are available to support the RegMW processes and resources in the most optimal way, in close partnership with relevant parties like Enabling Business Information Solutions.
Aligns RegMW processes and priorities to maximize RegMW and IDAR’s effectiveness; implements innovative approaches to enhance productivity and effectiveness.
Implements end-to-end document and reporting standards, and drives adherence to standards in trials/programs and regulatory submissions.
Oversees initiatives related to process improvements, regulatory compliance and other key department, cross-functional activities as assigned. Participates in and/or lead cross-functional and cross-sector initiatives.
Provides leadership to the RegMW team by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. The position is responsible to create an environment where employees feel engaged and empowered, and take pride in their role, responsibilities and deliverables.
This position will report to the Head of IDAR, and will ensure the execution of GCDO and IDAR mission and vision.
The Head of Regulatory Medical Writing is charged with making decisions associated with the management of assigned personnel and local administration, including hiring, performance management, space allocation, supplies, budget, travel, etc., so long as the decisions are in line with the approved company and department guidelines for headcount and spending. The Head of Regulatory Medical Writing is accountable for the decisions made by assigned employees within their scope and should review and approve actions as appropriate. The Head of Regulatory Medical Writing is responsible for, in consultation with IDAR Capabilities head and stakeholders, implementing new capabilities related to RegMW activities.
This position is an active promotor and driver to implement “good document management and writing practices” across the organization to ensure data quality and data integrity at all times for the areas in scope. The Head of Regulatory Medical Writing is responsible for aligning processes across projects within their scope and enforcing compliance with standards and IDAR processes.
QualificationsA minimum of a Bachelor’s degree (University/college degree) in a scientific discipline is required; and advanced degree (e.g., Masters, MBA, MD, PhD) is preferred.
At least 10 or more years of experience in clinical development areas with expert knowledge in medical writing, with proven and progressive leadership capabilities is required.
At least 5 or more years of project management and functional management is required. Demonstrated track record of working within a global matrix environment is required.
The following skills are required:Good knowledge of regulatory guidance documents such as ICH requirements.
Demonstrated written and/or communication skills.
Demonstrated leadership and decision making skills.
Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational & business challenges.
Demonstrated innovative thinking to allow for optimal execution of clinical development strategies.25% Domestic and International Travel is required.
The following knowledge, skills and abilities are strongly preferred:Proven expert in medical writing, with an understanding of the processes and technologies in pharmaceutical R&D, drug development and relevant therapeutic areas.
Trusted, inclusive leader with demonstrated experience in managing and monitoring cross functional, global, matrix teamsA strong and consistent track record of business results – strong execution; always meeting or exceeding goals and expectationsAble to think globally to ensure the objectives of IDAR and GCDO are met, while balancing the needs of the individual project teamsAbility to lead, inspire and influence team through rapidly changing organizational and business challengesProven ability to attract, retain, motivate, and develop best in class talent pipelineDemonstrated ability to collaborate internally and develop effective partnerships with key business partners and customersRefined oral and written communication skills, including effective negotiation, influencing, and active listeningStrong customer focus and belief in CredoPerformance in line with Leadership ImperativesBE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NAPrimary Location:North America-United States-New Jersey-RaritanOther Locations:North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: Janssen Research & Development, LLC. (6084)Job Function: Medical WritingCertain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. EEO is the Law EEO is the Law GINA Supplement