We are representing a patient-driven global Biopharmaceutical company in their search for a Senior Director for Global Medicine and R&D.
Why Join Us:
- Become a part of a team that takes on some of the toughest challenges in the industry to provide life-changing results for patients.
- An innovative company that has received the Prix Galien Award twice and has been recognized by Forbes on the “World’s Most Innovative Companies” list for seven consecutive years.
Expectations first 12 months:
- Help develop and implement the company’s ethics and compliance program covering R&D, Operations, Quality, External Funding and Global Medical activities
- Support the Head of R&D, Quality, Ops, Global Medical in providing Compliance guidance for pipeline development, clinical trials, management of 3rd party CROs, global medical and patient-facing activities.
- Independently drive the development, implementation and management of the compliance program, including policy, process, training, communication, programs and systems for R&D and Global Medical organization;
Principal Responsibilities
- Develops targeted guidance, policies and training to address R&D and Global Medical needs and supports key strategic approaches for compliance across the organization;
- Serves as a Compliance subject matter expert for R&D and Global Medical and partners with R&D and Medical Affairs leadership to set the strategic tone and align tactical direction for the organization;
- Supports integration of the global anti-bribery/anti-corruption compliance program into all these functional areas;
- Serves as a partner for compliance investigations and audits. Develops appropriate responses to investigations and audits, including remedial measures. Collaborates across departments to enhance, from an ethics and compliance perspective, business operations;
- Analyzes internal and external ethics and compliance developments and implements responses to these developments which enhance the global ethics and compliance program;
- Develops formal and informal communications to deliver compliance program key messages and build integrity culture;
- Provides compliance advice and support for the Investigator Sponsored Research and Collaborative Study review and approval process;
- Supports, from a Compliance perspective, Global Access to Medicine (GATM) Program and the Scientific Communications team (including MLR, Publications and Medical Information);
- Maintains updated understanding of requirements around DOJ and OIG reporting requirements; appropriate knowledge of guidelines under which MSLs can operate;
Qualifications:
- 12+ years of experience serving in a compliance, legal, regulatory or related role, with a majority of that experience in the pharmaceutical/medical device industries.
- Experience working on anti-bribery/anti-corruption compliance preferred.
- Deep functional knowledge of the elements of a pharmaceutical ethics and compliance program. Must possess a thorough knowledge and understanding of the pharmaceutical industry and its business operations.
- In-depth knowledge and understanding of pharmaceutical industry laws, regulations and guidelines, including privacy and protection, anti-corruption, customer/patient interactions, etc.
- BA/BS degree required; JD required
Relocation Policy:
No relocation package offered.
Application Process- Qualified professionals are to submit resume to Jessica Simpson at: jessica@conselium.com
Published by Conselium Executive Search, the global leader in compliance search.
