GSK

Medical Writing and Clinical Submissions Manager- ViiV

Employer
GSK
Location
Research Triangle Park, North Carolina; Collegeville, Pennsylvania
Salary
Competitive
Posted
October 30 2020
Ref
269651
Organization Type
Pharma
Job Type
Manager
Are you looking for a highly visible medical writing role that broadens your project management capabilities? If so this Medical Writing and Clinical Submissions Manager role could be an ideal opportunity to consider.

As a Scientific & Medical Writing Manager, you will lead therapy area specific medical writing projects or programs as appropriate in support of the clinical strategy to meet business and regulatory needs, and potentially leading projects across products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

  • Providing key contributions to clinical strategy, including knowledge and understanding of regional and global regulatory requirements for writing clinical documents including, but not limited to, protocols, clinical study reports, clinical study register summaries, common technical document summaries and Clinical Overview, briefing documents for regulatory authorities, responses to regulatory authority questions, clinical sections of the IMPD for clinical trial applications, investigator brochures and annual reports.
  • Leading matrix teams in planning and production of multiple clinical documents to support regulatory submissions worldwide, working with CROs and/or independent contractors as needed. Ensures global approach for submissions as appropriate, including the use of core global modules, supplemented by local modules as necessary. Ideally works in collaboration with GRA to ensure business needs are met for new chemical entities and post approval documentation.
  • Planing and successfully implements large submissions independently or in conjunction with the Medical Writing Director, effectively recommending methods or innovative solutions for achieving accelerated timelines as necessary. Recommends solutions for problems that affect timelines. Provides guidance and facilitation to submission teams in development of detailed submission plan.
  • Ideally demonstrates an understanding of the interdependences of various contributing functions and manages problems affecting timelines as necessary. Ideally demonstrates an ability to quickly assess complex situations, apply scientific, operational and submission development knowledge to identify and implement effective plans for solutions.
  • Proposing resourcing solutions for major projects including number of FTEs required and best use of internal and external resource.
  • Effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions. Acts as lead author on submissions.
  • Actively contribute to development of training materials for therapeutic area scientists and provides mentoring and/or training on clinical documentation and submission planning to individuals or teams. Ideally, proactively identifies medical writing training needs for staff and develops/implements training sessions.
  • Ability to prioritise effectively and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix, ensuring standards are proactively applied across a submission.


Why Y ou?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's Degree
  • Extensive scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implements effective plans and solutions.
  • Understanding and is ability to independently analyze/critique/assess trends and patterns in both text and statistical data and communicate findings clearly and succinctly in writing to a scientific/medical/regulatory audience. Has provided significant written contributions to regulatory submissions audience.
  • Solid scientific technical expertise and the ability to independently apply new knowledge and operational processes accordingly.
  • Excellent understanding of Good Clinical Practice (GCP), ICH guidelines for Common Technical Document and Code of Federal Regulations for New Drug Application and FDA requirements, and other regulations governing clinical research.
  • Significant experience in clinical research and development processes.
  • Thorough knowledge of major country regulatory requirements for clinical documents and has experience as a major contributor to clinical dossiers or major country regulatory submissions.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • PhD, PharmD, MPH, MS or other post-graduate degree
  • Highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at senior level.
  • Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
  • Ability to effectively lead and manage projects of increasing scope and complexity.
  • Demonstrated ability to champion change
  • Demonstrated familiarity with the role of other disciplines contributing to the overall drug development program such as clinical pharmacology.


Why ViiV?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As ViiV focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


If you require an accommodation or other assistance to apply for a job at ViiV, please contact the ViiV Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

ViiV is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

ViiV does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact ViiV's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to ViiV. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and ViiV. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of ViiV. ViiVshall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, ViiV may be required to capture and report expenses ViiV incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure ViiV's compliance to all federal and state US Transparency requirements. For more information, please visit ViiV's Transparency Reporting For the Record site.

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