Major global Bio/Pharmaceutical consulting organization, with a stellar industry reputation, seeks to add a Communications Executive to its leadership team for a breakthrough career opportunity. In this highly visible role you will assist with their on-going expansion plans domestically and internationally.

Description
Essential Function

• Global operational and functional leadership of scientific staff within SBU (all sites) to ensure efficient and profitable service delivery
• Accountable for achievement of defined scientific success metrics (e.g. utilization targets, P&L multiple, staff retention, recruitment, etc.)
• Responsible for scientific resource planning and allocation, and business planning
• Champion scientific and editorial quality standards and best practices: development and oversight of scientific and editorial policies and procedures; scientific and editorial training and development; smooth interface of scientific and editorial staff with other departments
• Participate in the development of new business opportunities (proposal development and client pitches), generation of scientific budgets and act as the most senior point of client contact on scientific matters
• Act as a role model and provide coaching and feedback to Managers' and scientific team
• Active member of the Senior Management Team and to work closely with the functional heads in achieving Operational excellence.

Relationships

• Reports to VP, Scientific and Editorial Services.
• Directly Supervises Managers, Scientific Strategy Advisors, and Administrators.
• Provides Work Direction to Manager, Scientific Writers, Scientific Specialists, Lead Scientific Specialists, Scientific Strategy Advisors, Administrators, Program Coordinators, Independent Contractors (ie, Freelance Writers).
• Works Closely With VP&GM, Directors, Managers, Scientific Strategy Advisors, Lead Scientific Specialists, Scientific Specialists, Scientific Writers, Editors, Editorial Specialists, Group Directors, Account Directors, Account Managers, Program Specialist, Senior Program Specialists, Project Coordinators, Independent Contractors, Creative Services, Meeting Services.
• External Relationships Clients, KOLs/Faculty, Independent Contractors, External Suppliers.

Key Accountabilities
Senior Management Team

• As an active member of the Senior Management Team contribute to business planning, problem-solving and the development and tactical implementation of the SBU strategy
• Build and maintain strong effective working relationships with the functional heads, to ensure co-operative and effective cross-functional working at all levels
• Develop and maintain a global approach, being sensitive to cultural and site-specific issues and fostering cross-site team building and co-operative working at all levels

Business Development and Planning

• Proactively develop effective working relationships with Business Development, Account Management, and other departmental Managers/Directors within MedCom and Corp. to ensure business objectives are achieved

- Partner with Business Development and Account Management

- provide strategic input to the development of proposals and pitch presentations

-participate in client pitch presentations

-provide/identify appropriate scientific expertise to support proposal/pitch development

-undertake/oversee accurate scientific budgeting

• Act as the most senior point of contact for clients on all scientific matters, e.g. scientific and editorial capabilities, identification of client needs, establishing appropriate policies and procedures, and addressing client dissatisfaction to ensure client satisfaction

Scientific Services Leadership

• Lead the SBU Scientific and Editorial Management group and proactively contribute to MedCom meetings and initiatives. Proactively lead identified cross-SBU initiatives, as required
• Set and implement vision, goals, and objectives for SBU Scientific Services
• Global day-to-day operational leadership and management of SBU Scientific Services to ensure client-focused, profitable, and timely delivery of all projects and programs to the highest of standards
• Develop a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced, and objective manner
• Act as a change advocate and effectively manage change within teams and across MedCom, as required
• Provide leadership, coaching, mentoring, and feedback to direct line reports and act as role model for Scientific Services
• Actively encourage global thinking at all levels, facilitating cross-site discussions and maintaining sensitivity to cultural and site-specific issues at all times
• In conjunction with Managers, conduct short-, medium- and long-term resource planning to identify resourcing and recruitment needs, allocating the resources necessary to manage SBU accounts effectively and efficiently: liaise with Managers to resolve as appropriate
• Undertake the full range of duties relevant to the leadership, management, and development of scientific services teams to ensure their performance meets and/or exceeds the business needs and provides their own personal goals/objectives
• In conjunction with the VP, S&E Services, initiate recruitment programs, undertaking initial filtering, telephone interviewing, and selection of editorial personnel to ensure the business attracts
• In conjunction with Managers, regularly review the performance, achievements, and development needs of scientific personnel in order to ensure that they have sufficient knowledge and skills to manage project/program activities to the highest standards, within agreed briefs, budgets, and timeframes
• Identify, in conjunction with Managers, skills-specific training needs for the scientific services team and ensure appropriate induction and training programs are developed and implemented
• Proactively manage performance of line reports: set and monitor SMART objectives, undertake timely performance reviews and quarterly follow ups, and address under-performance promptly and effectively
• Participate in formal staff review processes, eg, performance and salary reviews, to corporate standards and timescales
• Proactively manage SBU staff utilization to achieve set targets
• Assess and develop strategies to meet productivity and quality objectives. Develop mechanisms for monitoring progress and for intervention and problem-solving with key stakeholders
• Analyze data and reports to actively manage Scientific Services against key department metrics

Best Working Practices and Quality Control

• Oversee the scientific and editorial throughput of SBU globally; ensuring it is produced to the appropriate standard, to the required schedule, and within the agreed specification and budget.
• Provide direction to direct line reports on the effective set up and management of projects of all types, including printed, audio-visual, and electronic, from concept to final delivery
• Develop and champion implementation of, and ensure compliance to, best practice guidelines and SOPs. Continually review all editorial processes in order to identify improvements to working practices
• Ensure that all internal processes and procedures are established and followed, including those relating to approvals and sign-offs, kick-off and debrief meetings, and working practices with other departments/functions
• Ensure that corporate policies and procedures are understood and implemented effectively

Financial

• Oversee efficient scientific budgeting and support financial monitoring to maximize profitability of SBU accounts
• Review scientific services efficiency and profitability metrics and make recommendations for improvements

Additional Responsibilities

• Work closely with the Scientific and Editorial Director(s) and HR Department to ensure consistency of job roles, performance management, promotion criteria and packages
• Travel to other sites and to attend client meetings both in the UK and abroad is a requirement of this position

Experience
Skills

• Highly-developed motivational and leadership qualities demonstrated within a scientific and editorial team
• Solid scientific and editorial background, a depth and breadth of writing and editorial experience
• Strong client-focused approach to work, ability to relate to key client personnel and KOL/Faculty in an assertive and professional manner, confident handling of difficult scenarios or client dissatisfaction
• Strong ability to understand, develop, and implement scientific marketing strategy
• Excellent verbal and written communication and interpersonal skills, with proven ability to negotiate with other departments and resolve conflicts
• Effective project and resource management; proven ability to handle a broad range of clients and/or accounts
• Proactive, advanced problem-solving approach to team-specific and company-wide issues
• Proven ability to train and develop people and undertake skills assessment, identifying business needs, creating development plans to address gaps, and resolving performance issues promptly and effectively
• Aptitude for financial monitoring and efficiency assessment of projects
• Effective delegation skills
• Excellent writing, editing, and reviewing skills
• Excellent quality control (attention to detail, process application, consistency, and SOP adherence)
• A flexible approach with respect to work assignments
• Ability to manage multiple and varied tasks with proactive and to prioritize workload
• Willingness to work in a matrix environment and to value the importance of teamwork  Willingness to undertake continuous professional learning and development
• Highly IT literate ' advanced experience with Microsoft-based applications and general knowledge of PC functions
• Awareness of the use of technology to improve operational efficiencies

Education

• Degree or higher degree in Life Sciences, Pharmacy, or Medicine (BSc, BA, PharmD, PhD, MD)

Language Skills

• Proficient use of English language

Minimum Work Experience

• Extensive agency and management experience of a scientific team
• Broad experience in scientific and editorial management and delivery of the key offering and services within

MedCom

• Experience of reviewing, developing, and implementing editorial processes and effective working practices
• Possess a positive approach to change that encourages innovation and creativity
• Be willing to challenge and devise new approaches to communication techniques

Major global Bio/Pharmaceutical consulting organization, with a stellar industry reputation, seeks to add a Communications Specialist to its leadership team for a breakthrough career opportunity. In this highly visible role you will assist with their on-going expansion plans domestically and internationally.

Essential Functions

• Comprehensive understanding of the organization's service offerings and processes
• Develop high-quality scientific content by means of all necessary research, scientific writing, editing, and fact checking, to meet deadlines and working within project scope and objectives. Applies to all formats of MedCom's communication outputs
• Acquire and maintain expert knowledge of relevant therapy areas, client products, and objectives
• Act as the scientific account lead and take leadership role on project or program teams
• Take ownership of assigned projects or programs and take independent action to resolve complex technical issues to ensure excellent project delivery
  Liaise effectively with client and external authors/opinion leaders during the lifecycle of assigned projects or programs
• Work directly on projects or provide expert oversight of projects/programs being undertaken by other team members
• Provide leadership, mentorship, and direction to ensure the efficient delivery of high-quality outputs by the team
• Take prominent role in new business development activities

Key Accountabilities
Specialized Knowledge

• Demonstrate sufficient understanding of department's service offerings in order to:

    - Ensure that discussions with client are informed, appropriate, and consistent with MedCom's service offerings

    - Contribute to client solutions

• Be familiar and comply with all departmental procedures related to project delivery and tracking, promote adoption of these procedures by others, and recommend appropriate enhancements for efficiency
• Develop and maintain expert knowledge of client products and therapy areas on assigned accounts, and be recognized and sought after for expertise by internal team, client, and opinion leaders, providing consultative support as needed
• Develop and maintain in-depth knowledge of relevant industry guidelines (eg, Good Publications Practice); apply these to assigned projects and promote adherence by others
• Identify technical or process issues that are relevant to project delivery, and initiate, or work with other team members to initiate, appropriate actions
• Creatively and proactively apply specialist knowledge when working as part of a proposal and pitch development team, taking prominent role in pitch presentations as needed
• Share expertise proactively via one-to-one mentoring or via participation in formal training initiatives

Project Execution and Success

• Undertake writing and editing to develop high-quality scientific content
• Prioritize own work and manage project schedule to meet delivery deadlines
• Be familiar with and work within project scope (specification and budget hours) and objectives. Monitor project progress, scope changes, and own hours sufficiently to flag changes in scope to project lead, and proceed accordingly
• interpret scientific data accurately and appropriately
• Maintain familiarity with client objectives and messages and produce output consistent with these
• Undertake necessary research on topics relevant to assigned projects and maintain familiarity with available information sources
• Liaise with all opinion leaders/authors or other external parties in such a way as to foster strong and positive relationships and to ensure project success
• Identify issues that may affect project delivery and take independent action or liaise effectively with Manager and other team members, as appropriate, to resolve project issues
• Follow up on all assigned actions and proactively communicate status
• When overseeing the activities of other team members, make appropriate judgments on level of intervention and supervision required, so as to aid other s in their development as well as ensure successful project completion
• Maintain familiarity with, and adhere to, departmental SOPs (those related to quality control and all others), as well as propose enhancements and participate in implementation of these
• Seek opportunities to maximize project efficiency, identify and champion change to advance team performance, and lobby managers and colleagues as necessary
• Provide expert guidance to other team members on technical or process issues as necessary
• Provide expert mentorship and coaching of other team members, as necessary acting on own initiative to deliver this if necessary
• Communicate effectively and sensitively with team members across all functions
• Participate in or lead team discussions and meetings and contribute actively
• Develop creative and innovative ways to meet clients' communication objectives
• Effectively and comprehensively brief other team members or freelance contributors, as directed
• Provide expert review of others' work (in-house team members or freelance contributors)
• Use project experience to participate, as directed, in the development of accurate budgets

• Proactively build client relationships and manage client expectations, in conjunction with Account Management, ensuring client satisfaction and project profitability
• Identify complex technical and process issues, and lead resolution of these
• Be alert to opportunities to develop follow-on business
• Actively communicate and manage changes in project scope
• Maintain high level of client satisfaction with all interactions and deliverables
• Undertake discussions with client so as to actively manage timelines and expectations, maintaining client satisfaction throughout, and negotiate confidently with client on these matters (excepting budgetary, where internal consultation is necessary)

• Education: Bachelors Degree or higher in Life Sciences, Pharmacy, or Medicine (BSc, BA, PharmD, PhD, MD)
• Prior experience in a similar role within a medical communications agency environment
• Competent computer and Internet skills, including knowledge of MS applications such as Word, PowerPoint, and Excel
• Advanced oral and written communication skills
• Advanced problem-solving skills
• Technical expertise:

- Ability to acquire and apply specialized therapy area knowledge rapidly

- Good breadth of therapy area knowledge

- Ability to interpret and organize highly complex scientific data Ability to understand and

- implement marketing messages Scientific writing competency Proof reading and copyediting skills

- Ability to quality control own output according to editorial SOPs

• Effective project management skills
• Effective interpersonal skills and relationship-building competency
• Ability to lead project and program teams
• Strong client focus
• Ability to interact professionally within a client organization
• Ability to prioritize work and define steps needed to achieve specified project outcomes
• Ability to successfully manage assignments on time with high quality
• Strong presentation skills
• Strong mentoring skills
• Willingness to undertake continuous professional learning and development
• Willingness to work in a matrix environment and to value the importance of teamwork

• Discuss, develop, produce, revise and/or update protocols and clinical study reports for preclinical and clinical studies
• Responsible for developing IB?s, components of IND, Clinical Trial Authorization, NDA submissions, PFT, regulatory responses, and other clinical/regulatory documents
• Provide support to the assigned clinical development team to ensure clinical/regulatory document development needs and department standards are met, while completing projects within established schedules/timelines
• Facilitate conflict resolution across multi-disciplinary teams
• New drug application submissions, regulatory responses and other clinical document experience

• BSN/MS/PhD or PharmD required in biological, nursing or medical sciences
• 5+ years of relevant medical writing experience including protocol writing. Knowledge of PFT, eCTD and ICH document regulations
• Project Management experience with a strong track record of planning and organizational skills with minimal supervision
• Knowledge of the development, regulatory, quality and compliance environment within the pharmaceutical and marketing environment
• Strong interpersonal and communication skills
• Familiarity with ICH and AMA guidelines