Beschreibung
On behalf of one of our major clients, a leading multinational company, Randstad is actively looking for a: Senior Medical Scientific Expert for a 6 months contract
Responsible for providing medical and scientific input and expertise into medical brand teams and other brand related functions from pre-launch through the whole life cycle.
1. For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input to, eg:
a. Key activities related to planning, execution and reporting of Global Medical Affairs studies and ensures timely and on budget delivery.
b. Development of study related documents (eg concept sheets, protocols, case report forms, data analysis plan, study reports, publications).
c. Development of presentation material for study related advisory boards, investigator meetings, protocol training meetings for our client local medical organizations and speaker at meetings.
d. Ongoing review of clinical study data, final analysis and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team (GCT) members and the GBT (Global Brand Team).
2. Serve as a disease area scientific and medical expert for internal customers/stakeholders, eg, GCT, Scientific Review Committee, research, exploratory development, device development, Marketing, our client local medical organizations, and other line functions within GMA&HEOR and external customers eg, Key Opinion Leaders (KOLs) and patient advocacy groups.
3. Build together with the GBMD/Portfolio GBMD a highly influential medical and scientifically based platform:
a. Program/brand(s) publication plan and ensure execution in collaboration with assigned Medical Communication Leaders (MCLs), eg provide input on scientific content, support/lead data mining activities and support review processes associated with execution.
b. Support/lead internal and external medical education and communication initiatives (eg, speaker training, advocacy, KOL strategy, advisory boards, launch support, congress planning and execution).
4. provide medical scientific input For the assigned program/brand(s) to:
a. MA strategy and related MA plan
b. Development of Clinical Development Plan (CDP section related to MA activities)
c. Guidance and development of local MA clinical programs and provide support in execution
5. Support GBMD/portfolio GBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities.
6. Support or deputize GBMD/Portfolio GBMD in providing input into brand safety related activities for the assigned program.
7. Contribute to talent and career development of MA and Development colleagues like MCLs, SciOps, CTH, CM through active participation in on-boarding, training and mentoring activities.
Education:
- MD or PhD with unique knowledge for successful clinical program development and
execution, with 3 years of clinical research experience required. - Or
- MD with specialty with board certification or equivalent required.
Languages:
- Fluent English (oral and written)
Experience/Professional Requirement:
-Advanced medical/scientific writing and communication skills.
-Proven ability to interpret, discuss and represent efficacy and safety data relating to the assigned area.
-Proven ability to work both independently or in a cross functional team setting, including a Matrix environment.
-Demonstrated ability to establish effective working relationship with key investigators in assigned TA.
-Medical and/or scientific expertise within a disease area preferred.
Impact on the organization:
Impact on the execution of Medical Affairs plans (MA studies, Medical communication, KOL management)
Financial responsibility:
Clinical study budget for own MA studies
Decision making:
Together with GBMD/portfolio GBMD responsible for MA plans and associated activities
P&L/associates:
No direct reports